Clinical Research Coordinator Associate

Michigan Medicine; Ann Arbor (MI); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Retirement match

Job summary

Michigan Medicine seeks a Clinical Research Coordinator to coordinate multiple investigator-initiated studies, overseeing regulatory, recruitment, data collection, and operational needs. The role requires independent work, strong organizational skills, and experience with e-clinical tools.

The COE team emphasizes managing chronic pancreatitis studies and pain mechanisms, collaborating with investigators and sites, and maintaining high-quality data and participant safety across studies.

Qualifications

• Bachelor's degree in Health Science or equivalent required.
• ACRP-CCR CCRC or SoCRA-CCRP certification required or must be eligible and complete within 6 months.
• Minimum 2 years of related clinical research experience required.

Responsibilities

• Coordinate IRB applications and regulatory approvals.
• Maintain regulatory compliance through amendments and adverse-event reporting.
• Draft study protocols, consent forms, and SOPs.
• Screen for potential participants and obtain informed consent.
• Schedule visits and manage participant calendars.
• Enter and quality-check research data; resolve data queries.

Skills

Communication

Teamwork

Adaptability

Education

Bachelor's degree in Health Science or equivalent

Tools

MiChart/Epic

REDCap

Qualtrics

Job description

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.

Job Summary

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity, ranging from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities, resulting in high-quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to elevate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

The Division of Gastroenterology and Hepatology at the University of Michigan is seeking a highly organized Clinical Research Coordinator to join a multidisciplinary team conducting investigator-initiated studies of pancreatic diseases. The position will primarily support chronic pancreatitis research, with a focus on understanding pain mechanisms and evaluating novel approaches to pain management. The coordinator will work closely with investigators, research staff, participants, and collaborating sites to support the regulatory, recruitment, data-collection, and operational needs of several clinical studies. The position requires excellent interpersonal and organizational skills, attention to detail, comfort working with patients with chronic pain, and the ability to manage competing priorities across studies.

Responsibilities

Independent 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

Other Duties Include

• Coordinate study start-up activities, including preparation and submission of IRB applications and other required approvals.


• Maintain regulatory compliance through amendments, continuing reviews, adverse-event and protocol-deviation reporting, regulatory files, and communication with sponsors, contract research organizations, and central and local IRBs.


• Assist with drafting and maintaining study protocols, informed-consent documents, manuals of operations, standard operating procedures, and participant-facing materials.


• Develop and apply screening algorithms and identify potential participants through MiChart/Epic, DataDirect, clinic lists, and research registries.


• Prescreen potential participants, confirm eligibility with investigators, explain study procedures, obtain informed consent, and coordinate enrollment and randomization.


• Schedule and conduct remote and in-person study visits and maintain study calendars and participant-tracking systems.


• Conduct medical-record reviews and abstract clinical data.


• Administer surveys by email, text message, web link, paper form, or telephone using REDCap, Qualtrics, and other approved research systems.


• Perform quantitative sensory testing and other protocol-specific procedures after completing required training and competency assessments.


• Enter, maintain, and quality-check research data; respond to data queries; and help ensure data completeness, accuracy, and integrity.


• Maintain screening, enrollment, visit, retention, and withdrawal logs and monitor recruitment and study milestones.


• Document and elevate participant concerns, adverse events, protocol deviations, and other reportable events according to study procedures.


• Organize study meetings, prepare agendas and minutes, track action items, and communicate with investigators, project managers, and collaborating sites.


• Support monitoring visits, audits, database reconciliation, study closeout, and record archiving.


• Process participant payments, reconcile study expenses, monitor inventory, and purchase study supplies.


• Collaborate with other coordinators, research scholars, data manager, and the project manager.

Supervision Received

This position should report directly to a Clinical Research Coordinator Lead, Clinical Research Project Manager, Administrator, or Faculty Principal Investigator.

Supervision Exercised

None

Required Qualifications

• A bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary.


• Certification is required through the Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or the Society of Clinical Research Associates (SOCRA) as a Certified Clinical Research Professional (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.)


• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Desired Qualifications

• 4+ years of related experience in clinical research experience, including experience coordinating clinical trials.


• Experience with MiChart/Epic, regulatory submissions, REDCap, and Qualtrics.


• Experience recruiting, consenting, and retaining research participants.


• Familiarity with medical terminology and medical-record abstraction.


• Experience working in a large, complex healthcare or academic research environment.


• Ability to communicate effectively with participants, clinicians, investigators, staff, and collaborating institutions.


• Familiarity with University of Michigan policies and research procedures.

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

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

Work Schedule

This is a full-time position requiring 40 hours per week over five days. The position is eligible for a hybrid work arrangement, with four days onsite and up to one day working remotely each week, subject to study needs and departmental approval. Some flexibility may be required to accommodate participant visits, study deadlines, and occasional activities outside standard business hours.

Additional Information

Michigan Medicine (or unit-specific name) 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 Reporting 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 at any time after the minimum posting period has ended.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.