clinical research associate medpace

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What Does a Medpace Clinical Research Associate Do?

Find out what a Medpace Clinical Research Associate does, how to get this job, and what it takes to succeed as a Medpace Clinical Research Associate.

Medpace is a global clinical research organization that provides comprehensive clinical development services to the biopharmaceutical and medical device industries. They specialize in providing clinical trial management, regulatory affairs, data management, and other services to help bring new treatments to market.

A Clinical Research Associate at Medpace is responsible for managing clinical trials from start to finish. This includes developing study protocols, recruiting and training study staff, monitoring study sites, and ensuring compliance with all applicable regulations. The Clinical Research Associate is also responsible for collecting and analyzing data, preparing reports, and presenting results to the client.

Medpace Clinical Research Associate Job Duties

A Medpace Clinical Research Associate typically has a wide range of responsibilities, which can include:

• Monitor clinical trials in accordance with Good Clinical Practice (GCP) and applicable regulations
• Ensure that all study-related activities are conducted according to the protocol, SOPs, ICH/GCP guidelines, and local regulations
• Perform site selection, initiation, monitoring, and closeout visits for assigned studies
• Prepare and submit visit reports within specified timelines
• Review source documents for accuracy and completeness
• Track regulatory documents and ensure timely submission of required documents
• Assist in the development of project plans and budgets
• Provide guidance and training to sites on protocol requirements and GCP compliance
• Maintain effective communication with internal teams and external vendors
• Monitor data entry into electronic databases and review data listings for accuracy
• Participate in investigator meetings as needed
• Develop and maintain relationships with investigative sites

Medpace Clinical Research Associate Salary

The salary of a Clinical Research Associate at Medpace is determined by a variety of factors, including the individual’s experience and qualifications, the complexity of the job, the geographic location of the position, and the company’s budget. Additionally, the company may take into consideration the cost of living in the area, the availability of similar positions in the area, and the overall market demand for the position.

• Median Annual Salary: $82,926 ($39.87/hour)
• Top 10% Annual Salary: $112,270 ($53.98/hour)

Medpace Clinical Research Associate Job Requirements

To be hired as a Clinical Research Associate at Medpace, applicants must have a Bachelor’s degree in a scientific field, such as biology, chemistry, or a related field. Previous experience in clinical research is preferred, but not required. Additionally, applicants must have excellent communication and organizational skills, as well as the ability to work independently and as part of a team. Certification in Good Clinical Practice (GCP) is also preferred, but not required. Finally, applicants must be able to travel up to 25% of the time, as some clinical research sites may be located outside of the local area.

Medpace Clinical Research Associate Skills

Medpace Clinical Research Associate employees need the following skills in order to be successful:

Site Initiation Visits (SIVs): SIVs are the first time a clinical research associate visits a research site to assess its suitability for clinical trials. This is an important part of the job, as it ensures the site meets the standards of the clinical research industry. Clinical research associates must be able to assess a site’s facilities, staff and resources to determine if it’s a good fit for clinical trials.

Informed Consent: Informed consent is the process by which a research participant is informed about the details of a study, including the potential risks and benefits of participating. Clinical research associates must be able to explain study details to participants in a way that is clear and easy to understand. This requires clinical research associates to have a thorough understanding of the study protocol and procedures.

IRB: An associate working in a clinical research company’s IRB (Institutional Review Board) is responsible for ensuring that the company follows all regulations and laws regarding the treatment of human subjects. This position requires a thorough understanding of the regulations and laws, as well as the ability to interpret and apply them to the company’s research.

Good Clinical Practice (GCP): GCP is a set of standards that clinical research associates must follow to ensure the integrity of a study. These standards include ethical treatment of patients, accurate data collection and reporting and compliance with all regulations. Clinical research associates must be familiar with GCP to ensure the quality of the data they collect and the safety of the patients involved in the study.

Ethics Committee Approval Process: Clinical research associates must follow ethical guidelines when conducting research. This includes ensuring the safety of the participants and ensuring the research follows the guidelines set by the committee. Clinical research associates must also follow ethical guidelines when recording data and maintaining confidentiality.

Medpace Clinical Research Associate Work Environment

Medpace Clinical Research Associates (CRA) typically work in an office setting, but may also travel to clinical sites to monitor clinical trials. CRA’s typically work 40 hours per week, but may be required to work additional hours to meet deadlines or to complete tasks. CRA’s may also be required to travel to clinical sites to monitor clinical trials, which may require overnight stays. CRA’s must be able to work in a fast-paced environment and handle multiple tasks simultaneously. They must also be able to work independently and be able to handle stressful situations.

Medpace Clinical Research Associate Trends

Here are three trends influencing how Medpace Clinical Research Associate employees work.

Data Management

Data management is becoming increasingly important in the clinical research field. Medpace Clinical Research Associates must be able to manage and analyze large amounts of data from multiple sources, including patient records, laboratory results, and medical images. They must also be able to interpret this data accurately and efficiently.

Data management tools are being developed to help streamline the process of collecting, organizing, and analyzing data. These tools can help reduce errors and improve accuracy, as well as provide insights into trends that may not have been previously visible. As such, it is essential for Medpace Clinical Research Associates to understand how to use these tools effectively in order to maximize their efficiency and effectiveness.

The Role of the CRA During and After COVID-19

The role of the Clinical Research Associate (CRA) has become increasingly important during and after the COVID-19 pandemic. As clinical trials have been disrupted due to the pandemic, CRAs are now tasked with ensuring that protocols are followed and data is collected accurately.

CRAs must also be able to adapt quickly to changing regulations and guidelines in order to ensure compliance. Additionally, they must be able to effectively communicate with sponsors and sites to ensure that all parties involved understand the protocol and can work together to achieve successful outcomes.

The CRA’s role will continue to evolve as the industry recovers from the pandemic. It is essential for CRAs to stay up to date on new technologies and trends in order to remain competitive and provide the best possible service to their clients.

Patient Engagement in Clinical Trials

Patient engagement in clinical trials is becoming increasingly important as the healthcare industry shifts to a more patient-centric approach. Medpace Clinical Research Associates are at the forefront of this trend, working with patients and their families to ensure that they understand the risks and benefits associated with participating in a trial.

Patient engagement also helps to improve data quality by providing real-time feedback on how the trial is progressing. This allows for better decision making and faster results. Additionally, it can help to reduce costs associated with running a trial by reducing the need for additional resources or personnel. By understanding the importance of patient engagement, Medpace Clinical Research Associates will be well positioned to take advantage of this emerging trend.

Advancement Prospects

Clinical research associates can advance their careers by taking on more responsibility and gaining experience in different areas of clinical research. They may move up to a supervisory role, such as a clinical research manager, or they may move into a more specialized role, such as a clinical research coordinator or a clinical research scientist. They may also choose to pursue a higher degree in clinical research or a related field, such as a Master’s degree in Clinical Research Administration.

Interview Questions

Here are five common Medpace Clinical Research Associate interview questions and answers.

1. How would you handle an irate client?

This question can help interviewers assess your interpersonal skills and ability to handle challenging situations. In your answer, try to show that you have the patience and problem-solving skills to diffuse a tense situation and resolve it quickly.

Example: “I would first listen carefully to what they’re saying and ask questions if I don’t understand something. Then, I’d explain in simple terms why their concerns aren’t valid or how we are working on resolving them. If they continue to be upset, I would offer to speak with them privately so no one else has to hear their complaints.”

2. Have you worked with any regulatory documents before? What kind?

This question can help the interviewer understand your experience with regulatory documents and how you apply them to your work. You can use examples from previous jobs to show that you know what a regulatory document is, how it works and how to apply it to your research.

Example: “I have worked with several regulatory documents in my past roles as a clinical research associate. I’ve worked with both FDA and IRB regulations for all of my projects, which has helped me ensure that our company’s research was safe and ethical. I also used GCP guidelines when working on studies abroad, where we had to comply with local laws.”

3. What are some of your skills that would help make you successful as a Clinical Research Associate?

This question is an opportunity to highlight your relevant skills and abilities. When answering this question, it can be helpful to include a brief description of the skill or ability along with an example from your experience that shows how you use it.

Example: “I have excellent organizational skills, which I developed through my previous role as a medical records clerk at a hospital. This helped me keep track of patient information and ensure all documents were filed correctly. Another skill I possess is my attention to detail, which has helped me notice errors in data entry before sending reports to clients.”

4. What is your experience with data collection and management?

This question can help the interviewer understand your experience with clinical research and how you might fit into their team. Use examples from your previous job to highlight your skills, but also consider including any personal projects or volunteer work that helped you develop these skills.

Example: “In my last position as a medical researcher, I was responsible for collecting data on patient demographics, health history and treatment plans. This involved entering information into our database and ensuring it was accurate before sending it to the lead researchers. I also worked closely with other members of the team to ensure we were all using the same terminology when recording data.”

5. Tell me about a time when you were under a lot of pressure at work, what did you do to manage it?

This question can help the interviewer get a better idea of how you handle stressful situations. Use your answer to highlight your ability to work under pressure and remain calm, focused and productive.

Example: “I once had an extremely busy week at my previous job where I was working on several projects at once. One day, I received a call from one of our clients who needed some additional information about their study. I told them that I would look into it right away and find out what they needed. After finishing up with all of my other tasks for the day, I looked over the client’s file again and found the information they were looking for. They were very happy with my response.”

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Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

• United States (Remote)
• Posted 3 days ago

Website Medpace

Accelerating Drug, Biologic and Medical Device Clinical Development

Job Summary

Clinical Research Coordinators wanted at Medpace!  Become a CRA and join our growing team!

This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace.  Through our  PACE®  Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary.

WE OFFER THE FOLLOWING

• Competitive travel bonus;
• Equity/Stock Option program;
• Training completion and retention bonus
• Annual merit increases;
• 401K matching;
• The opportunity to work from home;
• Flexible work hours across days within a week;
• Retain airline reward miles and hotel reward points;
• Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere;
• In-house travel agents, reimbursement for airline club, and TSA pre-check;
• Opportunity for leadership positions – Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more;
• CRA training program ( PACE® );
• Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts;
• In-house administrative support for all levels of CRAs; and
• Opportunities to work with international team of CRAs.

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
• Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;
• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;
• Verification that the investigator is enrolling only eligible subjects;
• Regulatory document review;
• Medical device and/or investigational product/drug accountability and inventory;
• Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol;
• Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Qualifications

• Must have a minimum of a Bachelor’s degree in a health or science related field;
• Experience as a Clinical Research Coordinator (minimum 1 year);
• Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely;
• Must maintain a valid driver’s license and the ability to drive to monitoring sites;
• Proficient knowledge of Microsoft® Office;
• Strong communication and presentation skills; and
• Must be detail-oriented and efficient in time management.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Medpace Perks

• Hybrid work-from-home options (dependent upon position and level)
• Competitive PTO packages – starting at 20+ days
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Flexible work schedule
• Competitive compensation and benefits package
• Structured career paths with opportunities for professional growth
• Discounts for local businesses
• Recognized by Forbes as one of America’s Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

To apply for this job please visit uscareers-medpace.icims.com .