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Premier Episode of On Research Podcast – What is a Clinical Research Associate?

Season 1 – Episode 1 – What is a Clinical Research Associate?

A Clinical Research Associate (CRA) is a professional within a healthcare setting who oversees research activities, typically related to clinical trials. CRAs can be employed and work in a variety of sectors, including government agencies, pharmaceutical companies, research institutions, and in similar settings. Most CRAs possess an academic degree from a higher education institution in a field related to the healthcare industry. The overall role and tasks of a CRA are outlined and defined by good clinical practice guidelines for clinical trials.

Episode Transcript

Darren Gaddis : From CITI Program, I’m Darren Gaddis and this is On Research. Today, what is the difference between a clinical research associate and a clinical research professional? The skills and training needed to be a clinical research associate and general misconceptions about clinical research associates. I spoke with Elizabeth Waddell, owner and CEO of the CRA Helper.

She has been in the clinical research industry for over 20 years. Elizabeth began her career as an in-house clinical research associate and later transitioned to an on-site clinical research associate. After 14 years as a monitor, she transitioned from a senior clinical research associate to a line manager role focused on training new CRAs.

As a reminder, this podcast is for educational purposes only. It is not intended to provide legal advice or guidance. You should consult with your organization’s attorneys if you have questions or concerns about relevant laws and regulations discussed in this podcast. Additionally, the views expressed in this podcast are solely those of the presenter.

Hi Elizabeth. Thank you for joining me today.

Elizabeth Waddell : Hi Darren. Thank you so much for having me. I’m excited to be here.

Darren Gaddis : To get us started, what is a clinical research associate or CRA?

Elizabeth Waddell : So a clinical research associate, like you said, A CRA, and they’re also known as a monitor. I think the best way to explain what it is, is to start with why is it even required.

So per FDA regulations and GCPs, the sponsor must ensure that the clinical trials are properly monitored and this is to ensure the rights and the wellbeing of the human participants are protected, and they have to make sure the patients are safe. And on the flip side, they need to make sure, and ensure that the data from the clinical trial is accurate, complete and verifiable from source documents. And that the study’s being conducted in compliance with the protocol GCPs and reg requirements. So there’s a lot they have to monitor in a trial and that’s where we come in, that’s where the CRAs come in.

We must monitor the studies on behalf of the sponsor. And our two major obligations are ensuring subject safety and data integrity. And there’s even guidance regarding the selection of CRAs, as we must be qualified by the training and experience to monitor the progress of the trial. So it’s a very important role, as keeping patients safe and protected is so huge. And also verifying the validity of the data is huge, because for example, in a pharmaceutical trial, the FDA is reviewing this data to evaluate if a drug is safe. They’re evaluating if the drug is effective and that’s going to go into all that decision-making if a drug is approved or not. So it’s very important, monitoring the progress of a trial.

Darren Gaddis : And from that definition, what is the difference between a clinical research associate and clinical research professional?

Elizabeth Waddell : So a clinical research professional to me, is anyone in the clinical research industry. So a CRA would be an example of a clinical research professional. It’s one of the roles in the industry. There are so many roles as you’ll see from project managers to auditors to clinical trial associates, and then you have roles at the site level as well.

Darren Gaddis : From your own experience, could you describe the training and skills that one needs, to be successful as a CRA ?

Elizabeth Waddell : So I’ll start with the training. When we would review CVs, a curriculum vitae, it’s like a resume in the research world. When we would review CVS in order to interview a potential CRA candidate, we primarily looked at their education, as well as their clinical research experience.

So taking a CRA training per se, wasn’t something that was required. Again, we focused on the clinical research experience. Now, although a CRA training course is not required though, can it help build confidence? Absolutely.

So for example, when I was assigned to a study that was a new therapeutic area, in addition to training at our company, I would take extra trainings to build confidence when monitoring the disease under study. So it’s the same thing with a CRA training course that may not be a requirement to get the job, but if it can help you learn and build the confidence to perform the job better or even interview better, it is so worth it.

And the same thing, even certification being a certified CRA, it wasn’t necessarily a requirement for me, I didn’t have to be certified and actually I did my certification, or obtained it when I was a senior CRA.

My company offered, they were like, “Hey, we’ll pay for it, you have the time. Do you want to go for it?” And I’m like, “Oh my gosh, yeah that would be awesome!” So I did do it, and it’s an accomplishment for sure, and I’m glad to have it and I’m glad to have the credentials. But did I have to be certified to get a CRA job? I did not. So I do like to point that out. Definitely, clinical research experience on a CV speaks volumes, but again, you do the training more for yourself to help build that confidence.

As far as skills required, definitely, attention to detail. You will go through documents like a fine tooth comb, you definitely need to have those eagle eyes, attention to detail, and definitely critical thinking skills, because in research you’ll find that not a lot of things are black and white. It takes critical thinking, problem-solving, sometimes escalating things to different study team members.

I’ve been in research for 20 plus years and I still send emails like, “Hey, I’ve noticed this. This is what I’m thinking of, how to resolve the issue, what are your thoughts?”

And sometimes you have to consult with different departments. Not being afraid. Do not be afraid to ask questions. Again, like I talked about, you’re going to confirm things with different departments sometimes. And to me, asking questions is not a sign of weakness, it’s a sign of strength, because you want to do your job, you want to confirm things for your study.

And you definitely need to have time management skills, there are a lot of deadlines and metrics that you must meet, so definitely time management, being able to prioritize, and then being able to reprioritize, because there’s many times things are changing in clinical research, you may get an email that totally changes your day. So you’ll have to reprioritize what needs to be performed for that day. And like I mentioned, being able to adapt, being flexible, so these are some soft skills that you’ll need to have as well, as deal with different personalities.

Very important, as you’ll be not only with your study team, but you’re going to be going to many different sites and interacting with different people and things, so that’s important to have as well as being able to be organized, being able to work independently because again, you’re going to many sites working by yourself there, monitoring documents, as well as sometimes when you’re not on the road, you may be working remotely, at home in your office.

So you have to be able to still meet your deliverables, work independently and be able to communicate effectively. And not just verbally, but written communications is very important. Lots of trip report completion, email communication, lots of documentation as a CRA, so definitely written communication is so important. And I know there are many more skills I could probably point out, but I would say this is a good start of important skills to have.

Darren Gaddis : And with all of this in mind, would you be willing to share your own journey to becoming A CRA ?

Elizabeth Waddell : Yeah, sure. I graduated with a bachelor’s in clinical research, and while I was doing my internship, I interviewed to work in the lab actually, at a company that manufactured vaccines. And I was offered the job, but at the same time I received a call from a recruiter with an opportunity as an entry level in-house CRA, and I was like, “Oh wow, this is clinical research…”

My heart was just being tugged in that direction, and it ended up that I chose the in-house CRA opportunity and it was definitely a blessing. I first was contract, then I went permanent, and after about a year of being an in-house CRA, a CRA 1, I was promoted to a CRA 2, and then moved to the clinical department and started onsite monitoring. And the rest is history, here we are 20 years later.

Darren Gaddis : And from your own tenure, what is one general misconception about CRAs?

Elizabeth Waddell : In my experience, I would say one of the misconceptions about CRAs I would see, is people would picture, “Okay, CRAs, they come to a site and their role is to go to the site and pick them apart.”

And although sometimes I would, I’d be at a site and I’d see another monitor come in, and maybe they would have this air about them, like high and mighty. And they wouldn’t nicely point out issues that they observe. Sometimes that happens…

But the truth is we are a team with the site. So even though I may go to a site and I’m monitoring the study and I’m reviewing charts and reg docs and study drugs… And yes, I may discover or observe an issue, there’s a way that we treat our sites, and a respectful way to point out observations and also reeducate them because we want to help them, we’re there to help.

We also should work together with a site as a team, having that same goal of subject safety and data integrity. So that’s definitely a misconception that people have because there’s not one role that’s higher than the other. You have the site level and then you have a CRA that’s either with a sponsor or a CRO, and again, we’re all a team doing this clinical trial together.

Darren Gaddis : How could someone get their start as a CRA?

Elizabeth Waddell : Well, most CRA positions require at least a bachelor’s degree and usually in a scientific area or a scientific discipline is preferred. This of course would depend on the company. In addition, most entry level CRA roles require about one to three years of clinical research experience. Again, that’s going to depend on the company, but clinical research experience, like I mentioned, speaks volumes on a CV, so some ways that people may gain this experience in order to apply for an entry level CRA position, they can gain this clinical research experience like me, maybe starting out as an entry level in-house CRA, and then move to onsite monitoring. Or they may gain experience as a clinical trial associate or a project specialist or project coordinator. And some may gain experience at the site level, as a research assistant, or a clinical research coordinator, and they’re also known as a study coordinator.

And I always say that in my experience, study coordinators make great CRAs. So some people gain experience that way, and others may start with even a clinical research internship and start getting that experience under their belt that way. So unless a company has a position where they have their own training program and they do not require previous research experience, which there’s not many that I’ve seen, most of the time the companies will require at least one to three years of that previous clinical research experience. So it’s definitely important to have clinical research experience under your belt.

Darren Gaddis : And what else would you like to share with us about CRAs?

Elizabeth Waddell : Clinical research is a blessing, and to be a part of, and being a clinical research monitor, CRA is so rewarding. And also there are so many roles that it can lead to in the industry, like becoming a lead CRA or project manager, or even if you want to manage CRAs like becoming a line manager or QA auditor, or like me managing and training new CRAs, which I absolutely love. So there is so much growth in the industry. So that’s another great thing about it.

Darren Gaddis : Elizabeth, thank you for joining me today. Be sure to follow, like and subscribe to On Research with CITI Program to stay in the know.

I also invite you to review our content offerings regularly, as we are continually adding new courses and webinars that may be of interest to you. All of our content is available to you anytime through organizational and individual subscriptions. You may also be interested in CITI Program’s, Clinical Research Coordinator courses. Please visit CITI Program’s website to learn more about all of our offerings.

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Meet the Guest

Elizabeth Waddell, BS, CCRA – The CRA Helper Owner/CEO of The CRA Helper. I provide online training based on 20+ years of clinical research experience in order to help others pursue a career as a Clinical Research Associate.

Meet the Host

Darren Gaddis , Host, On Campus Podcast – CITI Program

He is the host of the CITI Program’s higher education podcast. Mr. Gaddis received his BA from University of North Florida, MA from The George Washington University, and is currently a doctoral student at Florida State University.

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Clinical Research Associate: Roles & Responsibilities

Introduction

Clinical research plays a pivotal role in advancing medical knowledge and patient care. At the heart of this process are Clinical Research Associates (CRAs), professionals who ensure the efficacy and safety of clinical trials. As the pharmaceutical and biotechnology industries expand, so does the demand for skilled CRAs. This blog aims to demystify the roles and responsibilities of a CRA and highlight the significance of this career in the realm of clinical research.

A Clinical Research Associate is a professional who monitors the administration and progress of a clinical trial (a research study that tests how well new medical approaches work in people). Typically, CRAs hold a degree in pharmacy, life sciences, nursing, or a related field, combined with substantial knowledge of clinical research protocols. They are the linchpins in the development of drugs, biologics, and medical devices, bridging the gap between the clinical trial process and regulatory compliance.

Key Responsibilities of a Clinical Research Associate

1. site selection and preparation.

CRAs are involved in selecting suitable sites for clinical trials, and assessing the capabilities of a site to conduct the trial. This involves evaluating the staff’s qualifications, the facility’s equipment, and the site’s patient population. They also play a key role in preparing the site for the study, ensuring that each site has the necessary materials and training to conduct the trial according to protocol.

2. Protocol Development and Implementation

CRAs contribute to developing the clinical trial protocol, a document that outlines the objectives, design, methodology, statistical considerations, and organization of a trial. They ensure that the trial is implemented as per the protocol and that any deviations are documented and justified.

3. Subject Recruitment and Consent

A crucial aspect of a CRA’s role is facilitating the recruitment of subjects for the trial. They ensure that potential subjects are properly informed about the trial and that informed consent is obtained in accordance with regulatory requirements.

4. Monitoring Clinical Trials

CRAs regularly visit trial sites to monitor the progress of the trial. They verify that the clinical trial data recorded by investigators is accurate and that the trial is being conducted in compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements.

5. Ensuring Compliance

CRAs ensure that clinical trials comply with regulatory standards and ethical guidelines. They are responsible for understanding and keeping up to date with regulations and guidelines, such as those set by the FDA or EMA.

6. Data Management and Reporting

Managing and overseeing the data collected during clinical trials is another key responsibility. CRAs review data for accuracy and completeness and assist in preparing reports on the trial’s findings.

Challenges Faced by Clinical Research Associates

CRAs often face challenges such as managing responsibilities across multiple trial sites, ensuring data integrity, and adapting to constantly changing regulatory environments. Problem-solving skills, adaptability, and a keen eye for detail are essential traits for success in this role.

The Future of Clinical Research Associates

The role of a CRA is evolving with advancements in technology and changes in the regulatory landscape. CRAs are increasingly involved in virtual or remote monitoring of trials, using digital tools to manage and oversee trial progress. As the field grows, so do the career paths and advancement opportunities for CRAs.

Clinical Research Associates play a critical role in the success of clinical trials. They ensure that trials are conducted ethically, efficiently, and in compliance with regulatory standards. The role of a CRA is not only challenging and demanding but also highly rewarding, contributing significantly to the advancement of medical research and patient care.

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Clinical research roles: how to become a clinical research associate, clinical research associate job description.

Clinical research associates (CRAs) are key actors in facilitating and ensuring successful clinical trial operations. A CRA in clinical research plays an essential role in the trial’s logistics, acting as a liaison between trial sites and the sponsor, and interacting with patients.

What is a clinical research associate?

A clinical research associate (CRA) is responsible for ensuring that clinical trials follow regulations, protocols, and Good Clinical Practice (GCP) guidelines.[ 1 ] The job description of a clinical research associate is centered on monitoring clinical trials to ensure they are conducted safely and effectively, and facilitating communication and coherence between sites and the sponsor. Their duties could include:

• Site selection: CRAs may be involved to varying degrees in selecting appropriate clinical trial sites as well as performing pre-trial site screening visits to verify their capacity to conduct the trial
• Protocol development: CRAs may help the sponsor/investigators develop the clinical trial protocol
• Study start up: CRAs assist with study start up activities, including obtaining regulatory approvals, collecting documentation, training site staff, and conducting site initiation visits
• Site visits: A core responsibility of the CRA is to visit the trial sites, both during the trial (to ensure protocol and regulatory compliance), and after the trial (to perform site close-out)
• Site monitoring: CRAs verify that sites are following the data management plan and protocols to help ensure data is accurate and complete
• Safety monitoring: CRAs may monitor patient safety throughout the trial, including adverse event reporting and serious adverse event management
• Regulatory compliance: CRAs ensure that clinical trials are conducted according to legal and ethical regulations and GCP guidelines

Other potential names for this position include clinical research monitor, clinical trials coordinator, clinical research scientist, or clinical research manager.

Qualifications: How to become a clinical research associate

To become a clinical research associate, you typically need a bachelor's degree in a relevant field such as biology, life sciences, or nursing. A degree in a field that is related to clinical research is generally preferred but is not required for all positions. Some employers may require additional qualifications, such as a master's degree or specialized certification.

In addition to formal education, experience working in the medical research industry is highly desirable. Many CRAs start their career in clinical research working under the supervision of experienced clinical research professionals.

Some of the skills needed to perform the job functions of a CRA include:

• Strong attention to detail and organizational skills
• Excellent communication and interpersonal skills
• Ability to work both independently and as part of teams
• Knowledge of the pharmaceutical and healthcare industries, health and life sciences, and clinical trial processes, regulations, and guidelines
• Analytical and problem-solving skills
• Proficiency in data management and analysis software

If you do not have a relevant degree or prior experience, there are still ways to break into the field of clinical research as a CRA. Here are a few tips:

• Look for entry-level clinical research jobs: Many companies offer entry-level clinical research associate jobs for individuals who do not have prior experience in clinical research. These positions may involve assisting CRAs with managing study activities or administrative tasks.
• Volunteer: Volunteering for clinical research organizations (CROs), research hospitals conducting trials, or other clinical research companies can provide valuable experience and demonstrate your interest in the field. Further, this experience may count as relevant work experience and could qualify you to take the ACRP CRA certification exam (see next section)

Clinical research associate certification

Several courses and clinical research certifications can help you land a CRA job. Two of the most in-demand clinical research associate certifications include SOCRA’s Certified Clinical Research Professional (CCRP) certification and the Association of Clinical Research Professionals (ACRP)’s Certified Clinical Research Associate (CCRA) certification.[ 2 ],[ 3 ] A CRA certification can help demonstrate your knowledge and skills to potential employers.

Similarly, the Certified Clinical Research Professionals Society (CCRPS) offers an Advanced Clinical Research Associate Certification (ACRAC) and course which covers clinical research protocols, clinical trials regulations set by the FDA, Good Clinical Practice (GCP), ICH guidelines, and more.[ 4 ] On a more general level, Coursera offers a specialized certification in Medical Terminology led by Rice University to help you get started on various career paths in the medical field.[ 5 ]

Where to look for clinical research associate jobs

Clinical research associates typically work for pharmaceutical companies, contract research organizations (CROs), academic institutions, or government agencies involved in conducting clinical research. They work closely with a team of clinical research professionals, including principal investigators (PIs), clinical research coordinators (CRC), data managers, and sponsors.

You may be able to find job openings directly with such companies by surveying their websites for open positions. However, you can also look for CRA jobs on job boards such as Indeed[ 6 ] or LinkedIn[ 7 ].

What is the average clinical research associate salary?

The average clinical research associate salary in the United States is around $81,826 (as of when this article was written), with a lower range of $49,052 and a higher range (senior clinical research associate salary) of around $136,499.[8] Salary will depend on multiple factors: level of experience, education, other certifications/qualifications, skillset, and the specific employer.

Clinical Research Associate job outlook

The job outlook for clinical research associates is quite positive, with the high demand for professionals in this field expected to continue. According to the Bureau of Labor Statistics, the employment of medical and health services managers, which includes clinical research associates, is projected to grow 28% between 2021 and 2031.[ 9 ]

In addition, the pharmaceutical and biotech industries are constantly developing new drugs and therapies, which must go through clinical trials before they can be approved. In the USA alone, there are currently over 400,000 active clinical trials.[ 10 ] Thus, there is high demand for professionals with the skills and knowledge to oversee these trials, ensure they are conducted safely and ethically, and optimize their success, particularly in the context of recent advances in technological adoption and new trial models. Moreover, CRA salaries have increased by an average of 15% over the past five years.[ 11 ]

Becoming a clinical research associate is a challenging yet rewarding career path requiring unique skills and qualifications. If you are passionate about medical research and want to make a difference in patients' lives, and you like working with diverse teams on large projects, this may be a promising career path for you. With the proper education, a CRA training program, and some relevant experience, you can become a vital part of the clinical research industry and contribute to the development of new treatments and therapies.

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An Examination of the Role of the Clinical Research Associate and Factors Impacting Performance and Experience

• Robert Howie
• Kenneth Getz, MBA

Study by Tufts CSDD uncovers potential reasons behind CRA shortages, turnover, experience requirements, and more.

The COVD-19 pandemic and changing global economies have impacted the clinical research workforce resulting in attrition, shortages, and staffing challenges. Current workforce shortages have posed numerous hurdles for clinical research stakeholders, including sponsors, investigative sites, contract research organizations (CROs), and industry associations. 1 The role of the clinical research associate (CRA) has been especially affected as high rates of turnover and vacancies proliferate. CRA turnover rates have been reported as high as 30% in the US with similar rates noted globally. 2

Recent research has examined current approaches to CRA training, performance assessment, and experience. The results of a global survey of 661 clinical research professionals, including 52 CRAs, assessing their own competencies indicated that respondents with more post-secondary education reported higher levels of self-confidence in their research skills and those professionally certified by the Association of Clinical Research Professionals (ACRP) and/or Society of Clinical Research Associates (SOCRA) compared to those who were not. Self-confidence also increased with the level of academic degree. 3 Researchers used a Joint Task Force (JTF) for Clinical Trial Competency Framework to assess respondents on eight competency domains. The results are consistent with prior research conducted in 2016. 4

The JTF for Clinical Trial Competency framework as discussed by ACRP “objectively defines the knowledge, skills, and attitudes necessary for conducting safe, ethical and high-quality research.” 5 Although common practice is currently to hire CRAs with two years of experience, high demands, vacancies, and attrition in the industry have led researchers to recognize a need to address the two years of required experience for those entering the clinical research workforce. Proposed solutions include conducting outreach to raise awareness of the profession, capturing measures of experience and transferable skills as well as add to competency-based training and innovative recruitment and retention approaches to attract candidates to the field. 5

An examination of the entry-level shortage of CRAs cites several factors including the requirement of a minimum of two years of work experience, high CRA turnover, increasing numbers of open CRA positions, and clinical trial growth and complexity. An assessment of a monitoring simulation of 579 CRAs from a global CRO indicates no difference in performance regardless of CRA seniority and years of experience. 6,7 The research also discusses that addressing the requirement of two years of experience for CRA roles would alleviate the current shortages in the workforce.

Given the impact of the changing clinical research industry on CRAs, Tufts CSDD investigated the current role of the CRA and critical issues including shortages and turnover, and approaches to CRA training and required experience. Also, the study examined the industry practice of two years’ experience as a hiring requirement and its relationship to CRA performance and recruitment and retention practices.*

*This research study was funded by Virb, Inc.

Methodology

The research used a dual methodology comprised of a web survey of pharmaceutical, biotechnology and CRO executives and an executive roundtable with industry experts. Tufts CSDD conducted an online survey prior to the meeting to gauge perceptions and insights about the role of the CRA based on a small group of clinical research professionals from the US Areas examined included years of experience required to become a CRA and type and effectiveness of training provided. In addition, the survey gathered perceptions about CRA shortages and attrition, most successful recruitment approaches and frequently used retention strategies. CRA assessment and performance were also investigated.

A roundtable meeting was held in October 2022 with 33 participants from biotechnology and pharmaceutical companies, CROs, academia, consulting, and technology. Participants provided their insights and perceptions across a broad range of topics including CRA assessment and training and the industry standard of requiring two years of work experience as a prerequisite to hiring. Other areas explored included recruitment and retention practices; the investigative site perspective; and the impact of outsourcing models, technology, and economic factors on the CRA role.

CRA survey demographics

The survey was distributed via a link to an e-mail invitation using Qualtrics software to industry executives in the US primarily working in clinical operations or clinical development. A total of 55 responses were collected between August and September 2022. Respondents represented a mix of company types with over half (56%, n=31) representing pharmaceutical or biotechnology companies; more than one-fourth (27%, n=15) from CROs and 16% (n=9) from other company types. The mean number of company employees was 17,581 with companies ranging in size from 4 to 95,000 employees. Respondents had 21 years of experience on average and an overwhelming majority (91%, n=50) identified their functional area as clinical operations or clinical development.

CRA training

In examining where CRAs typically receive training, a greater percentage of survey respondents indicated CRAs were trained by academia (62%, n=21) or company training programs (59%, n=20). Nearly 40% (38%, n=13) reported that ACRP provided training, while fewer (36%, n=12) noted specific programs or other types. The remainder (21%, n=7) mentioned SOCRA or Regulatory Affairs Professionals Society (RAPS). More than one-third of respondents (33%, n=11) reported that new CRAs receive three to four months of training at their organization.

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Clinical Researcher

Navigating a Career as a Clinical Research Professional: Where to Begin?

Clinical Researcher June 9, 2020

Clinical Researcher—June 2020 (Volume 34, Issue 6)

PEER REVIEWED

Bridget Kesling, MACPR; Carolynn Jones, DNP, MSPH, RN, FAAN; Jessica Fritter, MACPR; Marjorie V. Neidecker, PhD, MEng, RN, CCRP

Those seeking an initial career in clinical research often ask how they can “get a start” in the field. Some clinical research professionals may not have heard about clinical research careers until they landed that first job. Individuals sometimes report that they have entered the field “accidentally” and were not previously prepared. Those trying to enter the clinical research field lament that it is hard to “get your foot in the door,” even for entry-level jobs and even if you have clinical research education. An understanding of how individuals enter the field can be beneficial to newcomers who are targeting clinical research as a future career path, including those novices who are in an academic program for clinical research professionals.

We designed a survey to solicit information from students and alumni of an online academic clinical research graduate program offered by a large public university. The purpose of the survey was to gain information about how individuals have entered the field of clinical research; to identify facilitators and barriers of entering the field, including advice from seasoned practitioners; and to share the collected data with individuals who wanted to better understand employment prospects in clinical research.

Core competencies established and adopted for clinical research professionals in recent years have informed their training and education curricula and serve as a basis for evaluating and progressing in the major roles associated with the clinical research enterprise.{1,2} Further, entire academic programs have emerged to provide degree options for clinical research,{3,4} and academic research sites are focusing on standardized job descriptions.

For instance, Duke University re-structured its multiple clinical research job descriptions to streamline job titles and progression pathways using a competency-based, tiered approach. This led to advancement pathways and impacted institutional turnover rates in relevant research-related positions.{5,6} Other large clinical research sites or contract research organizations (CROs) have structured their onboarding and training according to clinical research core competencies. Indeed, major professional organizations and U.S. National Institutes of Health initiatives have adopted the Joint Task Force for Clinical Trial Competency as the gold standard approach to organizing training and certification.{7,8}

Recent research has revealed that academic medical centers, which employ a large number of clinical research professionals, are suffering from high staff turnover rates in this arena, with issues such as uncertainty of the job, dissatisfaction with training, and unclear professional development and role progression pathways being reported as culprits in this turnover.{9} Further, CROs report a significant shortage of clinical research associate (CRA) personnel.{10} Therefore, addressing factors that would help novices gain initial jobs would address an important workforce gap.

This mixed-methods survey study was initiated by a student of a clinical research graduate program at a large Midwest university who wanted to know how to find her first job in clinical research. Current students and alumni of the graduate program were invited to participate in an internet-based survey in the fall semester of 2018 via e-mails sent through the program listservs of current and graduated students from the program’s lead faculty. After the initial e-mail, two reminders were sent to prospective participants.

The survey specifically targeted students or alumni who had worked in clinical research. We purposefully avoided those students with no previous clinical research work experience, since they would not be able to discuss their pathway into the field. We collected basic demographic information, student’s enrollment status, information about their first clinical research position (including how it was attained), and narrative information to describe their professional progression in clinical research. Additional information was solicited about professional organization membership and certification, and about the impact of graduate education on the acquisition of clinical research jobs and/or role progression.

The survey was designed so that all data gathered (from both objective responses and open-ended responses) were anonymous. The survey was designed using the internet survey instrument Research Electronic Data Capture (REDCap), which is a secure, web-based application designed to support data capture for research studies. REDCap provides an intuitive interface for validated data entry; audit trails for tracking data manipulation and export procedures; automated export procedures for seamless data downloads to common statistical packages; and procedures for importing data from external sources.{11}

Data were exported to Excel files and summary data were used to describe results. Three questions solicited open-ended responses about how individuals learned about clinical research career options, how they obtained their first job, and their advice to novices seeking their first job in clinical research. Qualitative methods were used to identify themes from text responses. The project was submitted to the university’s institutional review board and was classified as exempt from requiring board oversight.

A total of 215 survey invitations were sent out to 90 current students and 125 graduates. Five surveys were returned as undeliverable. A total of 48 surveys (22.9%) were completed. Because the survey was designed to collect information from those who were working or have worked in clinical research, those individuals (n=5) who reported (in the first question) that they had never worked in clinical research were eliminated. After those adjustments, the total number completed surveys was 43 (a 20.5% completion rate).

The median age of the participants was 27 (range 22 to 59). The majority of respondents (89%) reported being currently employed as clinical research professionals and 80% were working in clinical research at the time of graduate program entry. The remaining respondents had worked in clinical research in the past. Collectively, participants’ clinical research experience ranged from less than one to 27 years.

Research assistant (20.9%) and clinical research coordinator (16.3%) were the most common first clinical research roles reported. However, a wide range of job titles were also reported. When comparing entry-level job titles of participants to their current job title, 28 (74%) respondents reported a higher level job title currently, compared to 10 (26%) who still had the same job title.

Twenty-four (65%) respondents were currently working at an academic medical center, with the remaining working with community medical centers or private practices (n=3); site management organizations or CROs (n=2); pharmaceutical or device companies (n=4); or the federal government (n=1).

Three respondents (8%) indicated that their employer used individualized development plans to aid in planning for professional advancement. We also asked if their current employer provided opportunities for professional growth and advancement. Among academic medical center respondents, 16 (67%) indicated in the affirmative. Respondents also affirmed growth opportunities in other employment settings, with the exception of one respondent working in government and one respondent working in a community medical center.

Twenty-five respondents indicated membership to a professional association, and of those, 60% reported being certified by either the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

Open-Ended Responses

We asked three open-ended questions to gain personal perspectives of respondents about how they chose clinical research as a career, how they entered the field, and their advice for novices entering the profession. Participants typed narrative responses.

“Why did you decide to pursue a career in clinical research?”

This question was asked to find out how individuals made the decision to initially consider clinical research as a career. Only one person in the survey had exposure to clinical research as a career option in high school, and three learned about such career options as college undergraduates. One participant worked in clinical research as a transition to medical school, two as a transition to a doctoral degree program, and two with the desire to move from a bench (basic science) career to a clinical research career.

After college, individuals either happened across clinical research as a career “by accident” or through people they met. Some participants expressed that they found clinical research careers interesting (n=6) and provided an opportunity to contribute to patients or improvements in healthcare (n=7).

“How did you find out about your first job in clinical research?”

Qualitative responses were solicited to obtain information on how participants found their first jobs in clinical research. The major themes that were revealed are sorted in Figure 1.

Figure 1: How First Jobs in Clinical Research Were Found

Some reported finding their initial job through an institution’s job posting.

“I worked in the hospital in the clinical lab. I heard of the opening after I earned my bachelor’s and applied.”

Others reported finding about their clinical research position through the internet. Several did not know about clinical research roles before exploring a job posting.

“In reviewing jobs online, I noticed my BS degree fit the criteria to apply for a job in clinical research. I knew nothing about the field.”

“My friend recommended I look into jobs with a CRO because I wanted to transition out of a production laboratory.”

“I responded to an ad. I didn’t really know that research could be a profession though. I didn’t know anything about the field, principles, or daily activities.”

Some of the respondents reported moving into a permanent position after a role as an intern.

“My first clinical job came from an internship I did in my undergrad in basic sleep research. I thought I wanted to get into patient therapies, so I was able to transfer to addiction clinical trials from a basic science lab. And the clinical data management I did as an undergrad turned into a job after a few months.”

“I obtained a job directly from my graduate school practicum.”

“My research assistant internship [as an] undergrad provided some patient enrollment and consenting experience and led to a CRO position.”

Networking and referrals were other themes that respondents indicated had a direct impact on them finding initial employment in clinical research.

“I received a job opportunity (notice of an opening) through my e-mail from the graduate program.”

“I was a medical secretary for a physician who did research and he needed a full-time coordinator for a new study.”

“I was recommended by my manager at the time.”

“A friend had a similar position at the time. I was interested in learning more about the clinical research coordinator position.”

“What advice do you have for students and new graduates trying to enter their first role in clinical research?”

We found respondents (n=30) sorted into four distinct categories: 1) a general attitude/approach to job searching, 2) acquisition of knowledge/experience, 3) actions taken to get a position, and 4) personal attributes as a clinical research professional in their first job.

Respondents stressed the importance of flexibility and persistence (general attitude/approach) when seeking jobs. Moreover, 16 respondents stressed the importance of learning as much as they could about clinical research and gaining as much experience as they could in their jobs, encouraging them to ask a lot of questions. They also stressed a broader understanding of the clinical research enterprise, the impact that clinical research professional roles have on study participants and future patients, and the global nature of the enterprise.

“Apply for all research positions that sound interesting to you. Even if you don’t meet all the requirements, still apply.”

“Be persistent and flexible. Be willing to learn new skills and take on new responsibilities. This will help develop your own niche within a group/organization while creating opportunities for advancement.”

“Be flexible with salary requirements earlier in your career and push yourself to learn more [about the industry’s] standards [on] a global scale.”

“Be ever ready to adapt and change along with your projects, science, and policy. Never forget the journey the patients are on and that we are here to advance and support it.”

“Learning the big picture, how everything intertwines and works together, will really help you progress in the field.”

In addition to learning as much as one can about roles, skills, and the enterprise as a whole, advice was given to shadow or intern whenever possible—formally or through networking—and to be willing to start with a smaller company or with a lower position. The respondents stressed that novices entering the field will advance in their careers as they continue to gain knowledge and experience, and as they broaden their network of colleagues.

“Take the best opportunity available to you and work your way up, regardless [if it is] at clinical trial site or in industry.”

“Getting as much experience as possible is important; and learning about different career paths is important (i.e., not everyone wants or needs to be a coordinator, not everyone goes to graduate school to get a PhD, etc.).”

“(A graduate) program is beneficial as it provides an opportunity to learn the basics that would otherwise accompany a few years of entry-level work experience.”

“Never let an opportunity pass you up. Reach out directly to decision-makers via e-mail or telephone—don’t just rely on a job application website. Be willing to start at the bottom. Absolutely, and I cannot stress this enough, [you should] get experience at the site level, even if it’s just an internship or [as a] volunteer. I honestly feel that you need the site perspective to have success at the CRO or pharma level.”

Several personal behaviors were also stressed by respondents, such as knowing how to set boundaries, understanding how to demonstrate what they know, and ability to advocate for their progression. Themes such as doing a good job, communicating well, being a good team player, and sharing your passion also emerged.

“Be a team player, ask questions, and have a good attitude.”

“Be eager to share your passion and drive. Although you may lack clinical research experience, your knowledge and ambition can impress potential employers.”

“[A] HUGE thing is learning to sell yourself. Many people I work with at my current CRO have such excellent experience, and they are in low-level positions because they didn’t know how to negotiate/advocate for themselves as an employee.”

This mixed-methods study used purposeful sampling of students in an academic clinical research program to gain an understanding of how novices to the field find their initial jobs in the clinical research enterprise; how to transition to a clinical research career; and how to find opportunities for career advancement. There are multiple clinical research careers and employers (see Figure 2) available to individuals working in the clinical research enterprise.

Figure 2: Employers and Sample Careers

Despite the need for employees in the broad field of clinical research, finding a pathway to enter the field can be difficult for novices. The lack of knowledge about clinical research as a career option at the high school and college level points to an opportunity for broader inclusion of these careers in high school and undergraduate curricula, or as an option for guidance counselors to be aware of and share with students.

Because most clinical research jobs appear to require previous experience in order to gain entry, novices are often put into a “Catch-22” situation. However, once hired, upward mobility does exist, and was demonstrated in this survey. Mobility in clinical research careers (moving up and general turnover) may occur for a variety of reasons—usually to achieve a higher salary, to benefit from an improved work environment, or to thwart a perceived lack of progression opportunity.{9}

During COVID-19, there may be hiring freezes or furloughs of clinical research staff, but those personnel issues are predicted to be temporary. Burnout has also been reported as an issue among study coordinators, due to research study complexity and workload issues.{12} Moreover, the lack of individualized development planning revealed by our sample may indicate a unique workforce development need across roles of clinical research professionals.

This survey study is limited in that it is a small sample taken specifically from a narrow cohort of individuals who had obtained or were seeking a graduate degree in clinical research at a single institution. The study only surveyed those currently working in or who have a work history in clinical research. Moreover, the majority of respondents were employed at an academic medical center, which may not fully reflect the general population of clinical research professionals.

It was heartening to see the positive advancement in job titles for those individuals who had been employed in clinical research at program entry, compared to when they responded to the survey. However, the sample was too small to draw reliable correlations about job seeking or progression.

Although finding one’s first job in clinical research can be a lengthy and discouraging process, it is important to know that the opportunities are endless. Search in employment sites such as Indeed.com, but also search within job postings for targeted companies or research sites such as biopharmguy.com (see Table 1). Created a LinkedIn account and join groups and make connections. Participants in this study offered sound advice and tips for success in landing a job (see Figure 3).

Table 1: Sample Details from an Indeed.Com Job Search

Note: WCG = WIRB Copernicus Group

Figure 3: Twelve Tips for Finding Your First Job

• Seek out internships and volunteer opportunities
• Network, network, network
• Be flexible and persistent
• Learn as much as possible about clinical research
• Consider a degree in clinical research
• Ask a lot of questions of professionals working in the field
• Apply for all research positions that interest you, even if you think you are not qualified
• Be willing to learn new skills and take on new responsibilities
• Take the best opportunity available to you and work your way up
• Learn to sell yourself
• Sharpen communication (written and oral) and other soft skills
• Create an ePortfolio or LinkedIn account

Being willing to start at the ground level and working upwards was described as a positive approach because moving up does happen, and sometimes quickly. Also, learning soft skills in communication and networking were other suggested strategies. Gaining education in clinical research is one way to begin to acquire knowledge and applied skills and opportunities to network with experienced classmates who are currently working in the field.

Most individuals entering an academic program have found success in obtaining an initial job in clinical research, often before graduation. In fact, the student initiating the survey found a position in a CRO before graduation.

• Sonstein S, Seltzer J, Li R, Jones C, Silva H, Daemen E. 2014. Moving from compliance to competency: a harmonized core competency framework for the clinical research professional. Clinical Researcher 28(3):17–23. doi:10.14524/CR-14-00002R1.1. https://acrpnet.org/crjune2014/
• Sonstein S, Brouwer RN, Gluck W, et al. 2018. Leveling the joint task force core competencies for clinical research professionals. Therap Innov Reg Sci .
• Jones CT, Benner J, Jelinek K, et al. 2016. Academic preparation in clinical research: experience from the field. Clinical Researcher 30(6):32–7. doi:10.14524/CR-16-0020. https://acrpnet.org/2016/12/01/academic-preparation-in-clinical-research-experience-from-the-field/
• Jones CT, Gladson B, Butler J. 2015. Academic programs that produce clinical research professionals. DIA Global Forum 7:16–9.
• Brouwer RN, Deeter C, Hannah D, et al. 2017. Using competencies to transform clinical research job classifications. J Res Admin 48:11–25.
• Stroo M, Ashfaw K, Deeter C, et al. 2020. Impact of implementing a competency-based job framework for clinical research professionals on employee turnover. J Clin Transl Sci.
• Calvin-Naylor N, Jones C, Wartak M, et al. 2017. Education and training of clinical and translational study investigators and research coordinators: a competency-based approach. J Clin Transl Sci 1:16–25. doi:10.1017/cts.2016.2
• Development, Implementation and Assessment of Novel Training in Domain-based Competencies (DIAMOND). Center for Leading Innovation and Collaboration (CLIC). 2019. https://clic-ctsa.org/diamond
• Clinical Trials Talent Survey Report. 2018. http://www.appliedclinicaltrialsonline.com/node/351341/done?sid=15167
• Causey M. 2020. CRO workforce turnover hits new high. ACRP Blog . https://acrpnet.org/2020/01/08/cro-workforce-turnover-hits-new-high/
• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. 2009. Research electronic data capture (REDCap): a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42:377–81.
• Gwede CK, Johnson DJ, Roberts C, Cantor AB. 2005. Burnout in clinical research coordinators in the United States. Oncol Nursing Forum 32:1123–30.

A portion of this work was supported by the OSU CCTS, CTSA Grant #UL01TT002733.

Bridget Kesling, MACPR, ( [email protected] ) is a Project Management Analyst with IQVIA in Durham, N.C.

Carolynn Jones, DNP, MSPH, RN, FAAN, ( [email protected] ) is an Associate Professor of Clinical Nursing at The Ohio State University College of Nursing, Co-Director of Workforce Development for the university’s Center for Clinical and Translational Science, and Director of the university’s Master of Clinical Research program.

Jessica Fritter, MACPR, ( [email protected] ) is a Clinical Research Administration Manager at Nationwide Children’s Hospital and an Instructor for the Master of Clinical Research program at The Ohio State University.

Marjorie V. Neidecker, PhD, MEng, RN, CCRP,  ( [email protected] ) is an Assistant Professor of Clinical Nursing at The Ohio State University Colleges of Nursing and Pharmacy.

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What does a Clinical Research Associate do?

Published November 5, 2022 4 min read

A clinical research associate (CRA) is a professional who monitors and manages clinical trials. CRAs are typically employed by pharmaceutical companies, contract research organizations (CROs), and academic institutions.

Clinical Research Associate job duties include:

• Design and implement clinical research protocols
• Obtain IRB approval for clinical research studies
• Recruit and screen participants for clinical research studies
• Conduct clinical research studies in accordance with approved protocols
• Collect and manage data from clinical research studies
• Monitor participant safety during clinical research studies
• Close out clinical research studies in a timely manner
• Prepare and submit reports to sponsors and/or regulatory agencies
• Present results of clinical research studies at scientific meetings

Clinical Research Associate Job Requirements

A Clinical Research Associate (CRA) is a professional who monitors and manages clinical trials. CRAs are typically employed by pharmaceutical companies, contract research organizations, or academic medical centers. They may also be self-employed. The job requires a bachelor’s degree in a scientific discipline, although a master’s degree or higher is preferred. In addition, CRAs must be certified by the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA). Experience in the field is also required, and most CRAs have at least five years of experience.

Clinical Research Associate Skills

• Clinical research
• Good communication skills
• Organizational skills
• Writing skills
• Computer skills
• Detail oriented
• Ability to work independently
• Time management skills
• Problem solving skills
• Critical thinking skills
• Interpersonal skills

Related : Top Clinical Research Associate Skills: Definition and Examples

How to become a Clinical Research Associate

A Clinical Research Associate (CRA) is a professional who monitors and manages clinical trials. CRAs are responsible for ensuring that trials are conducted according to the protocol and that they meet all applicable regulations. They also work closely with investigators to ensure that the trial is conducted safely and efficiently.

Becoming a CRA requires at least a bachelor’s degree in a scientific discipline, although many CRAs have advanced degrees. In addition, CRAs must have strong communication and organizational skills and be able to work independently. They must also be detail-oriented and able to maintain accurate records.

There are several ways to become a CRA. Many CRAs start their careers as research coordinators or research nurses. Others may have experience working in the pharmaceutical industry or in regulatory affairs. Some CRAs may also have previous experience working in clinical research as study coordinators or project managers.

The best way to become a CRA is to get experience working in clinical research. There are many ways to do this, including volunteering, working as a research assistant, or participating in a clinical trial as a patient or healthy volunteer. Working as a CRA is a demanding job, but it can be very rewarding. Those who are successful in this career help bring new treatments and cures to patients who need them.

Related : Clinical Research Associate Resume Example

Related : Clinical Research Associate Interview Questions (With Example Answers)

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Research Associate Vs Clinical Research Associate

The differences between research associates and clinical research associates can be seen in a few details. Each job has different responsibilities and duties. It typically takes 1-2 years to become both a research associate and a clinical research associate. Additionally, a clinical research associate has an average salary of $62,966, which is higher than the $60,166 average annual salary of a research associate.

The top three skills for a research associate include patients, research projects and data analysis. The most important skills for a clinical research associate are patients, informed consent, and CRA.

Research associate vs clinical research associate overview

What does a research associate do.

A research associate is responsible for assisting the research team, organizing and interpreting findings, and verifying information before presenting the study to the board. Research associates duties also include gathering and comparing data from multiple sources, analyzing the current industry trends, creating draft outlines for reports, collecting individual contacts for interview purposes, and helping with the development of research procedures. A research associate must have excellent time-management skills and ability to multi-task, especially on meeting strict deadlines and conducting studies.

What does a clinical research associate do?

A clinical research associate is responsible for assisting medical professionals in clinical trials and conducting research studies on medications and medical procedures. Clinical research associates monitor the research materials, ensuring its safety and reliability through trial procedures, writing comprehensive reports of results, and disseminating information across the concerned parties. They also provide recommendations on improving clinical processes, reiterating protocol requirements, and maintaining strict confidentiality of the trial subjects. A clinical research associate must have extensive knowledge of the medical industry, including its disciplines and principles, to perform duties accurately under minimal supervision.

Research associate vs clinical research associate salary

Research associates and clinical research associates have different pay scales, as shown below.

Differences between research associate and clinical research associate education

There are a few differences between a research associate and a clinical research associate in terms of educational background:

Research associate vs clinical research associate demographics

Here are the differences between research associates' and clinical research associates' demographics:

Differences between research associate and clinical research associate duties and responsibilities

Research associate example responsibilities..

• Study utilize online survey tools and data are managed and analyze using SPSS.
• Manage databases, analyze data in STATA, and summarize relevant findings for partners.
• Lead diverse research teams in the development of PCR and reverse transcriptase PCR assays for various food-borne pathogens.
• Process, analyze and upload HTS data that lead to the discovery of new structural classes of small molecules.
• Manage outsource projects, and interact with vendors for API sourcing, and device components base on project needs.
• Manage all aspects of HPLC method development and analysis through interpretation of data ensuring accuracy of results.

Clinical Research Associate Example Responsibilities.

• Manage, schedule and train up to 15 CRAs.
• Recruit patients, attain patient inform consent form, educate subjects on compliance, and ensure patient safety per ICH guidelines.
• Manage site TMF to ensure communication requirements adherence
• Manage CRO and regional monitor to complete close out activities, including device accountability management.
• Manage regional academic and community base oncology practices as the primary contact for all communications and support.
• Manage the monitoring CRO and the data clean-up efforts for a 510k submission and interim/annual study reports by effectively collaborating cross-functionally.

Research associate vs clinical research associate skills

• Patients, 6%
• Research Projects, 6%
• Data Analysis, 6%
• Data Collection, 5%
• Cell Culture, 5%
• Chemistry, 4%
• Patients, 9%
• Informed Consent, 7%
• Clinical Trials, 6%
• Clinical Trial Management, 5%
• Oncology, 4%

Research Associate vs. Similar Jobs

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• Research Associate vs Clinical Research Associate

Research Associate Related Careers

• Assistant Research Scientist
• Clinical Research Associate
• Graduate Research Student
• Laboratory Researcher
• Postdoctoral Research Associate
• Research And Development Scientist
• Research And Development Technician
• Research Chemist
• Research Consultant
• Research Fellow
• Research Internship
• Research Laboratory Technician
• Research Leader
• Research Project Coordinator
• Research Scientist

Research Associate Related Jobs

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• Research Internship Employment Near Me
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• Research Scientist Employment Near Me

Research Associate Jobs By Location

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Clinical Research Associate vs Coordinator (CRA vs CRC)

What is a cra/crc.

Use this guide to get a detailed side-by-side comparison of two similar acronyms with 2 very different roles.

The clinical research coordinator or CRC helps conduct the trial as one specific site and will archive all the documents at the site when the verification by CRA is complete.

The clinical research associate or CRA will review and verify documents from multiple sites conducting the same trial and do multiple visits to ensure quality and ethical conduct of the clinical trial .

CRA vs CRC (Clinical Research Coordinator vs Associate)

Clinical Research Associate vs Coordinator

Difference between clinical research associate and coordinator:

A  clinical research associate  ( CRA ), also called a  clinical monitor  or  trial monitor , is a research professional with a minimum of a bachelors degree (usually nurses!) who works under contracts or hired by sponsors, CROs, or freelancing (by biopharma and research institutes) to perform roles listed in ICH GCP guidelines for monitoring clinical trials.

Who makes up the research team?

A CRA ensures compliance with ICH GCP and the clinical trial protocol by checking clinical site activities, making on-site visits (selection, initiation, routine, close-out), verifying “trial” case report forms (CRFs) are accurate by comparing to medical records, and speaking with the site’s CRC.

CRAs protect the ethical safety of human subjects and ensure the scientific integrity of the data collected through these processes.

Difference between clinical research coordinator and clinical research associate:

When a PI (principal investigator, i.e. often a busy, working physician running a trial on the side) is chosen to conduct a trial at their site, clinical research coordinators often take over part of the essential responsibilities of PI. This includes making sure the trial is 1) conducted and 2) in compliance with the protocol and federal or international regulations.

Site (CRC) vs. Sponsor (CRA)

CRC vs CRA: CRC responsibilities include writing the IRB/Ethics Committee application (specific to each site unless trial is under a single IRB/sIRB), making/performing informed consent (IC) process, developing a budget for the site, subject recruitment, patient care, adverse event reporting (a CRA simply audits and ensures that no AEs were missed!), preparing the case report form (CRF) for the CRA to review against medical records, and submitting tons of data and records to the CRA/Sponsor at each site visit.

Roles of a CRA

CRA interactions with other fields

Roles of a CRC

CRC interactions with other fields

Clinical Research Associate vs Coordinator Salary

Because CRAs manage multiple trial sites at one time, have a bachelors degree (minimum), and produce outcomes that are cost-effective for improving the efficiency of a trial; clinical research associates usually get paid more than coordinators. Unfortunately, clinical research coordinators are really doing the brunt of the “front-line” work and are the reason the trial occurs at that site all together. CRCs take a huge responsibility in both starting the trial and then presenting the trial documents to the CRAs as well as being the “middle-man” of the entire Site vs. Sponsor/CRO communication line. While CRCs deserve to get paid more, of course, it is not cost-effective as there are usually multiple sites and thus budgets are not capable of expanding upon the CRC’s pay-range. Luckily, CRC’s with experience can bridge to becoming a CRA through certifications and exams.

Clinical Research Associate (CRA)

$70k on average, from $60K-$97K

Clinical Research Coordinator (CRC)

$50k on average, from $30K-$70K

CRC to CRA bridge program

You can bridge into being a CRA in your own company or apply for jobs to be a CRA by completing CRA certification and trying to get experience with any on-site “in house” CRAs your site may have. CCRPS provides advanced “senior”-level CRA certification for CRCs so that:

1) on resumes you can prove knowledge competency of CRA tasks up to an advanced level (easier for in-job promotion)

2) during interviews you can prove your application of knowledge

3) during the job itself you can be efficient and diligent in preventing errors.

Clinical Research Coordinator Salary

Clinical research associate salary - what's the pay for a clinic research associate.

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Clinical Research Coordinator Associate (On-site)

Researchers are driven by possibility. As a Clinical Research Coordinator Associate (On-site), you will be a central force in our mission to ensure equity of care across the globe. With an opportunity to continue your professional development and interact with some of the top minds in medicine, your possibility-driven approach will have a profound impact on the lives of patients. As we work to make sure everyone has access to safe, innovative treatments, our NIH ranking and the backing of Stanford Medicine will help ensure that you have the resources you need to succeed. Join us at Stanford School of Medicine, where we are better with you.

• Level: Entry Level
• Travel: Minimal (if any)
• Salary: $63K-$96K

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Success Profile

What makes a successful Clinical Research Coordinator Associate (On-site) at Stanford Medicine? Check out the traits we’re looking for and see if you have the right mix.

• Team Player
• Communicator
• Detail-Oriented
• Trustworthy

Career Path

• Assistant Clinical Research Coordinator leads to Clinical Research Coordinator Associate
• Clinical Research Coordinator Associate leads to Clinical Research Coordinator 2 or Medical Degree (MD) or Physician Assistant (PA) Program Medical Degree (MD) or Physician Assistant (PA) Program
• Clinical Research Coordinator 2 leads to Clinical Research Manager
• Clinical Research Manager

Employee Benefits

Comprehensive health and welfare benefits, unmatched time away benefits, unique education benefits, work-life programs, stanford sweeteners, job description.

Clinical Research Coordinator for Large Neuroimaging Study of Aging and Alzheimer’s disease

The Mormino Lab within the Department of Neurology and Neurological Sciences is seeking a Clinical Research Coordinator Associate (CRCA) to work on new projects involving high-frequency data collection in older adults. Data modalities span technology-focused data (e.g., item location tracking through Bluetooth devices, actigraphy), questionnaire data, and biological data (e.g., biofluids, neuroimaging). Data collection will occur at Stanford as well as in the research participant’s home. These projects are related to the Stanford Aging and Memory Study (SAMS), an ongoing longitudinal imaging-biofluid study of healthy aging. The primary focus of this position will be to contribute to data collection and analysis on NIH- and privately-funded projects studying the diagnosis and monitoring of neurodegenerative diseases including Alzheimer’s disease, enabling early detection, and understanding the contributions of early pathology to cognitive decline in human aging.

The CRCA will have the opportunity to collaborate with our interdisciplinary team including researchers from multiple scientific disciplines including psychology, cognitive neuroscience, electrical engineering, anesthesiology, neuropsychology, and neurology. The successful candidate will participate in all aspects of research in the lab, including: in-person and telephone recruitment of research participants; obtaining informed consent; scheduling and coordination of research participant visits involving technological devices, biofluids, and MRI; maintaining longitudinal contact with participants by phone, email and other means; transcribing and analyzing audio data; analyzing and assessing data quality; and contributing to manuscript preparation. The candidate must be organized, problem solving oriented, have strong communication skills, and thrive in collaborative team environments. A commitment of two years is highly desired.

In addition to submitting your online CV/resume, include a cover letter describing your prior experience with human research.

Duties include:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.
• Plan and perform research tasks of limited complexity requiring initiative and judgment in applying basic knowledge and understanding of scientific theory when precedents do not provide specific guidance; general instruction is provided by the supervisor.
• Administer questionnaires and rating scales requiring judgment in applying non-routine scoring procedures.

*- Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Ability and desire to work well with older adults
• Excellent verbal and written communication skills.
• Ability to work independently and proactively, with good organizational skills.
• 2+ years of related experience in subject recruitment, assessment, and analysis
• Ability to work under deadlines with general guidance
• Proficiency with basic programming and scripts
• Experience with software packages statistics, such as R
• Proficiency with Microsoft Office and Excel

EDUCATION & EXPERIENCE (REQUIRED):

Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

PHYSICAL REQUIREMENTS*:

• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

• Occasional evening and weekend hours
• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to blood, chemicals, body fluid or tissues and risk of exposure to contagious diseases and infections

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

This position is fully onsite.

The expected pay range for this position is $27.88 to $36.54 per hour.

Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website ( https://cardinalatwork.stanford.edu/benefits-rewards ) provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.

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Stanford University has the unique benefit of being both well-established and intent on the future. As one of the most influential academic institutions in the world, our thought leaders, staff and cutting-edge, collaborative culture have fueled our belief in every possibility.

Testimonial

The pandemic has made it difficult for me to transition back into research. Once I started working at Stanford of Medicine, I immediately felt welcomed and supported. This institution has provided me with great opportunities to explore different kinds of research that can contribute to the field of precision medicine. It’s a great place for growth and to have my goals supported. –Guillermina Michel, Clinical Research Coordinator Associate – Anesthesia

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