clinical research coordinator university of miami

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Joslin Diabetes Center

Clinical research coordinator i (immunobiology).

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As a member of the clinical research team, the Clinical Research Coordinator I contributes to the conduct of a portfolio of clinical research protocols related to the prevention and treatment of type 1 diabetes. The Coordinator works with study participants and their families and performs a variety of study operations duties.

Responsibilities

• In all activities, adhere to Good Clinical Practice guidelines and maintain patient confidentiality per HIPAA regulations
• Identify potentially eligible participants using appropriate data sources
• Assess eligibility of potential study participants
• Become familiar with relevant content of all relevant study protocols
• Communicate clinical trial updates to other team members
• Describe studies to potential participants, explain rationale for and details of participation
• Obtain informed consent and assent, when appropriate
• Schedule study visits and prepare relevant materials for each visit (tubes, paperwork, etc.)
• Arrange participant travel, as applicable
• Collect primary data from study participants and their guardians
• After completing training, perform phlebotomy, measure vital signs, perform EKG and other relevant procedures and tests
• Ensure that study visits and source documents are completed in accordance with study protocols, including verifying the work of other staff members
• Enter data into electronic data capture forms and respond to queries
• Process laboratory samples and ship to central laboratories
• Ensure timely reporting of abnormal findings to investigator and participants
• Document and communicate all serious adverse events and other safety reports to the study team and investigator
• Maintain up-to-date inventory of study supplies and place orders
• Modify study documents, such as informed consent form and recruitment materials, when needed
• Prepare documents for submission to IRB—may include initial protocol submissions, protocol amendments, annual continuing review, etc.
• Maintain all regulatory and subject binders in audit-ready condition
• Correspond with study sponsors, contract research organizations, and other collaborators, as applicable
• Assist with study start-up and close-out activities, as relevant
• Participate in study teleconferences, attend team meetings, and attend national meetings and/or investigator meetings, as relevant (may involve travel)
• Participate in occasional off-site recruitment events (requires some schedule flexibility)
• Other duties as assigned

Qualifications

• Bachelor’s degree (in a relevant field of study preferred)
• 0-2 years of relevant post-graduate experience preferred
• Fluency in written and spoken English
• Basic knowledge of Microsoft Office Suite and ability to navigate at a basic level within various web-based applications.
• Graphic design/layout skills (to design brochures, flyers, etc.) desirable
• Ability to follow general instructions and procedures, as provided.
• Strong interpersonal, organizational and communication skills (communicate clearly and effectively via verbal and written instruction).
• Meticulous attention to detail
• Professional and warm in demeanor, especially when relating to study participants and their families
• Ability to maintain confidentiality
• Ability to prioritize responsibilities – through completion.
• Ability to work independently and with others in the team – to interact respectfully with other employees, professional staff and/or external contacts.
• Excellent critical thinking and problem-solving abilities
• Ability to learn sophisticated concepts and detailed protocols quickly
• Ability to work with minimal oversight, after training period
• Ability to manage administrative complexity arising from multiple concurrent studies
• Flexible schedule as necessary to accommodate study patients and recruitment activities

Joslin is an Equal Opportunity Employer of Minority/Female/Individuals with Disabilities/Protected Veterans. Joslin values diversity and inclusion, and we encourage diversity applicants.

Joslin Diabetes Center is an Equal Opportunity Employer and it is the policy of Joslin to prohibit discrimination of any type and to afford equal employment opportunities to employees, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, marital/parental status, disability status, protected veteran status or any other status protected by law.

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Engaging clinical research, medicare coverage analysis.

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Engaging Clinical Research at the University of Miami

The National Institutes of Health defines clinical research as “Research with human subjects that is:

• Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
• Epidemiological and behavioral studies.
• Outcomes research and health services research

Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition. 

An NIH video provides an overview of recent NIH policies affecting Human Subjects Research and Clinical Trials. 

One of the recent policies affecting clinical research requires applicants to submit a plan for the dissemination of NIH-funded clinical trial information that will address how expectations of the policy were met.  The NIH Policy on Dissemination of Clinical Trial information applies to applications submitted on or after January 18, 2017 that request support for the conduct of a clinical trial.  The ORA Guidance on the Dissemination Plan  provides guidance on NIH's review of the dissemination plan and terms of award.  

Clinical research entails various UM offices, forms and policies shown in the links below.  Faculty and administrators should become familiar with these areas which involve contracting, budgeting and billing.

Here you will find helpful information for engaging clinical research, including Jackson Forms, Signature Approval Routing Workflow and the Clinical Research Participant Enrollment & Tracking Policy.

• NIH Clinical Trial Questionnaire
• JHS Involved Clinical Trial Process

The Office of Research Administration builds Medicare Coverage Analysis.

Office of Research Administration

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Job Opening: Clinical Research Coordinator 1

Current Employees:

If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here (https://www.myworkday.com/umiami/d/task/1422$7248.htmld) to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER_eRecruiting_ApplyforaJob.pdf) .

The department of Psychiatry has an exciting opportunity for a full-time Clinical Research Coordinator 1. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties, and assumes responsibility for simple clinical research protocols and timelines.

CORE FUNCTIONS

Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.

Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.

Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.

Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.

Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.

Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.

Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.

Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.

Knows the contents and maintenance of study-specific clinical research regulatory binders.

Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.

Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS

Bachelor’s degree in relevant field required

Minimum 1 year of relevant experience

Knowledge, Skills and Attitudes:

Skill in completing assignments accurately and with attention to detail.

Ability to analyze, organize and prioritize work under pressure while meeting deadlines.

Ability to process and handle confidential information with discretion.

Ability to work evenings, nights, and weekends as necessary.

Commitment to the University’s core values.

Ability to work independently and/or in a collaborative environment.

Department Specifics

The CRC 1 will report to Dr. Vilma Gabbay and serve on projects with a multidisciplinary and collaborative team. Projects include innovative MRI-based imaging approaches, investigations of neuroinflammation, and the use of behavioral paradigms to probe reward processing in mood and anxiety disorders in adults and adolescents. CRC 1s will have the opportunity to gain excellent clinical and research experience, with the potential for publication.

The coordinator will handle the process of conducting research studies and related projects. Responsibilities include any combination of research participant-related activities such as recruitment, screening, psychiatric assessment, data collection, analysis, and management using electronic data capture systems, interaction with patient’s treatment team, imaging acquisition, and preparation of manuscripts. The CRC 1 will ensure that studies are conducted according to protocol design and will report deviations as they arise, and maintain study files such as regulatory documents, correspondence, case report forms and data files. They will perform activities related to regulatory compliance such as IRB submissions, mandates issued by the study sponsor, and any other regulatory entity.

The ideal candidate for this position will have a strong background in neuroscience or psychology with previous research experience. The position will be hybrid with the option to do fieldwork in either New York City or Miami, and involves a five day work week that may include weekend effort.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here (https://www.hr.miami.edu/careers/eo-ada/index.html) for additional information.

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Clinical Research Coordinator Lead

How to apply.

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

The Department of Obstetrics and Gynecology seeks an experienced Clinical Research Professional to manage and assist with several gynecology research studies and help grow the GYN Chronic Pain Program.   The ideal candidate will have previous research experience in women's health, project management, recruitment, and will serve as a resource and contact person for multiple active research protocols, research sites and staff. In addition to administrative dues, the candidate will engage with patients seen within UofM OBGYN and the community for recruitment, enrollment, specimen, and data collection in studies; capture data from medical records and enter into various data systems; communicate with patients regarding study purpose, study activities, and research appointments; create documents for accurate tracking and support faculty and fellows in the Division of Gynecology. This position requires a flexible schedule, with some evening coverage.

CRC STATEMENT:

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Lead position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems.  In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

Responsibilities*

Expert level knowledge, skills, and abilities within all 8 competency domains is expected:

• Scientific Concepts and Research Design
• Ethical Participant Safety Considerations
• Investigational Products Development and Regulation
• Clinical Study Operations (GCPs)
• Study and Site Management
• Data Management and Informatics
• Leadership and Professionalism
• Communication and Teamwork

Specific duties will include:

Project Management and Administrative Responsibilities

• Establishes operational objectives and assignments, and defines and manages project resource needs including project staff.
• Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolved
• Manage a portfolio of multi-site clinical research, when the University of Michigan is the lead center
• Supports and runs weekly and monthly research meetings
• Reviews study forms, databases, regulatory files, and all study related work for completion and accuracy
• Develops standard operating procedures, work-aids and other guidance
• Creates protocols for specimen collection, processing, shipping, etc., and implements procedures to maintain accuracy and efficiency
• Continually review and evaluate progress of projects and studies in order to identify problems, improve quality and implement solutions or improvements
• Collaborate with PIs, and liaison to Clinical Trial Service Units, on strategic project resource planning including assisting with staff and study need
• Work within CTSU framework for initiating and oversight of multiple studies with billing calendars  
• Assist with writing timely reports for funding agencies
• Assist with preparation of power point slides and visual abstracts of research studies related data
• Trains and supports study team members
• Recruit and train appropriate personnel for clinical research
• Provide supervision of students and temporary employees
• Work with administrative units to procure supplies for projects
• Assist PIs and study team members on various duties related to gynecology research as need
• Provide coordination for multiple clinical research studies of various complexity
• Ensure clinical research projects completed within specifications
• Coordinate research efforts with multiple principal investigators, research staff, clinical schedules, and research subjects.
• Communicate with IDS (Research Pharmacy) to order investigational drugs and make sure all protocol supplies are on stock.
• Collaborates with medical staff to facilitate and optimize the care of research patients
• Develop and monitor protocols and infrastructure for clinical studies
• Track, document and report on study progress
• Investigate, modify, and integrate new procedures as needed
• Serve as primary liaison between study staff, subjects, investigators, other departments, and sponsors.

Clinical Coordination Responsibilities

• Review real time medical records to match potential research participants with inclusion/exclusion criteria for active studies
• Assist with development and implementation of recruitment strategies targeted diverse participants within and outside of Michigan Medicine (including community-based recruitment)
• Travel to various local sites for screening and recruitment
• Approach women in person or on the phone, giving study overview, while being sensitive to environment and patients involved.
• Explain study thoroughly, review informed consent document, answer questions, and obtain consent
• Schedule subject visits, follow up interactions as well as coordinating with PI schedules
• Coordinate subject incentive payment submissions and tracking
• Maintain accurate and complete documents including, but not limited to: source documentation, study drug dispense/return logs, subject logs, and all study-related communications.
• Request and collect specimens, as well as properly prepare and ship specimens to outside institutions according to study protocol requirements.
• Attain in-depth understanding of several study protocols and objectives to assist with successful implementation of all study procedures
• Run and oversee specialized research devices and equipment

Data Related

• Create documents and databases for screening and recruitment
• Prepare datasheets, questionnaires, study related documents
• Complete subject documentation and follow up in online system  
• Responsible for data abstraction, entry, management, cleaning and database creation for several studies
• Triage complex data concerns, create reports on the completeness and quality of the collected data
• Various data related duties as needed

Regulatory & Study reporting

• Assist Regulatory specialist in preparing and maintaining, IRB (eResearch) applications including new applications, scheduled continuing reviews, amendments, adverse event reporting (events that either occurs in UM research subjects or subjects from other centers in multi-site studies) and other reportable information and occurrences.
• Facilitates monitoring or DSMB meetings
• Schedules, prepares for, and attends study initiation meetings, monitor visits, and audits
• Working with Research Pharmacy, study medication and chain of custody
• Attend and participate in meetings with study team to discuss subject enrollment and issues as well as study progress. Participate in protocol initiation and monitoring visits by study sponsors.
• Assist PI with identifying and grading adverse events.
• Ensure compliance with GCP, ICH, GOG and FDA regulations, standards and guidelines.
• Ensure compliance with study protocols, good clinical practice guidelines and FDA regulations
• Coordinate and facilitate any regulatory and institutional monitoring visits
• Provides training and mentorship of other clinical research staff on a range of communication and teamwork best practices; maintains certification)
• Completes Michigan Medicine training for Managing Successfully and Leading Successfully.
• Attends and participates in all training assigned to this level.

Supervision Received:

This position reports directly to the Department Senior Research Manager and Director of the Endometriosis and Pelvic Pain Research Group.

Supervision Exercised:

Possibly provide Functional supervision, in a limited capacity, such as training of staff in titles within the CRC Career Ladder.

Required Qualifications*

• Bachelor's degree or an equivalent combination of related education and experience is necessary.
• Certification is required through Association of Clinical Research Professionals ( ACRP ) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association ( SOCRA ) as a Certified Clinical Research Professionals (CCRP) or equivalent.   Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc . within six months of date of hire.   (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
• Demonstrate ability to work successfully while meeting competing deadlines
• Excellent interpersonal skills
• Demonstrated ability to prioritize and exercise good judgement
• Attention to detail and accuracy
• Primary activities are performed independently, and decisions are made free from immediate direction.
• Excellent communication skills, with the ability to receive and convey information clearly and concisely for various mediums.
• Excellent interpersonal and organizational skills, and the ability to work effectively with diverse groups
• A high degree of initiative and resourcefulness
• Demonstrated problem solving, conflict resolution, analytical, and critical thinking skills
• Demonstrates the ability to create and manage databases.
• Demonstrated ability to work well under time constraints and meet deadlines
• Demonstrated coordination, time management and communication skills
• Capable of conducting all start-up, active implementation, and closeout activities.

Level Specific Requirements:

• CRC Governance Committee review and approval 
• Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.
• Minimum 5+ years of directly related experience in clinical research and clinical trials is necessary

Desired Qualifications*

• 6+ years of direct related experience
• Experience with the OnCore clinical trial management system (CTMS)
• Previous experience with MiChart, RedCap, and Qualtrics

Work Schedule

Monday-Friday; hours vary depending on the study needs; general hours are within the 7am-6pm range. Some evening (5pm-9pm) hours may be required depending on the study needs.

Work Locations

• Primary location is at the main medical campus in University Hospital South (UH South); with regular work activities at VonVoigtlander Women's Hospital.
• This position may include some travel to Michigan Medicine clinical sites such as East Ann Arbor, Brighton, Chelsea, etc.
• Some remote work may be allowed depending on study needs.

Additional Information

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe. 

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.