Clinical Research Coord Inter

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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 and/or project management for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties 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.

Responsibilities*

Characteristic Duties and Responsibilities:

Set-up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) in 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

This position serves as a mid-level Clinical Research Coordinator (CRC) in the Pediatric Critical Care Medicine Division (PCCM/PICU) at the University of Michigan C.S. Mott Children's Hospital.

The coordinator supports clinical research activities across a portfolio of pediatric critical care studies, working closely with the PICU Clinical Research Project Manager, Principal Investigators, research staff, and clinical care teams to identify eligible participants, facilitate bedside recruitment and informed consent, coordinate study procedures, collect and process specimens, and manage research data. Additional responsibilities include assisting with regulatory documentation, maintaining study records, and supporting quality assurance activities to ensure compliance with approved protocols, institutional policies, and applicable regulatory requirements.

The division is also establishing a UG3-funded, multicenter research consortium focused on developing a harmonized U.S. cohort of children hospitalized with viral lower respiratory tract infections across nine sites, with longitudinal participant follow-up. As the project becomes operational, the coordinator may assist with regulatory submissions, study start-up activities, harmonization of regulatory processes across participating sites, and ongoing coordination with the Principal Investigator, study leadership, and collaborating research teams.

The successful candidate will demonstrate strong organizational, communication, and problem-solving skills, attention to detail, and the ability to work effectively both independently and collaboratively in a fast-paced clinical environment. The role offers opportunities to develop clinical research coordination skills and assume additional study responsibilities as experience and program needs evolve.

Flexibility in work hours is required to support time-sensitive research activities in the PICU, including participant screening, enrollment, and specimen processing that may occur during evenings or weekends.

Key responsibilities include:

• Screen, recruit, and obtain informed consent from eligible research participants in accordance with approved study protocols
• Coordinate study visits, participant follow-up, and other protocol-required activities
• Collect, process, store, ship and track research specimens, ensuring integrity and compliance with protocol and regulatory requirements
• Support multiple concurrent studies, prioritizing tasks and timelines effectively
• Maintain accurate source documentation and study data; perform quality assurance/quality control activities
• Coordinate data collection, entry, and management across assigned clinical research studies, ensuring accuracy, completeness, and adherence to study protocols and data management plans
• Respond to data queries from sponsors, coordinating centers, and collaborating research sites and ensure timely resolution and documentation
• Perform routine data quality checks to identify missing, inconsistent, or inaccurate information and implement appropriate corrections
• Collaborate with multidisciplinary teams, including clinicians, nurses, research pharmacy, and administrative staff, to support protocol adherence and resolve operational issues
• Assist with IRB regulatory processes including study start-up, amendments, continuing reviews, and safety reporting
• Support study start-up and regulatory coordination for multicenter research initiatives, including harmonization of regulatory processes across participating sites as needed
• Document and route adverse events (AEs) and serious adverse events (SAEs) in accordance with institutional, sponsor, and regulatory requirements
• Identify and troubleshoot study-related, participant, and workflow challenges
• Contribute to the development and refinement of research workflows, procedures, and supporting documentation
• Communicate with sponsors, clinical trial support units, and collaborating research teams regarding study progress, recruitment, and operational considerations

Supervision Received:

This position reports to the CRC Project Manager, division Ddministrative Director and the Faculty Principal Investigator.

Supervision Exercised:

This position supports a portfolio of multi-site clinical research in which the University of Michigan is the lead center; functionally supervising junior staff as needed under delegated authority from the Project Manager.

Required Qualifications*

• Excellent interpersonal, verbal, and written communication skills with strong attention to detail
• Proficiency in Microsoft Office applications
• Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines
• Willingness to be flexible in a dynamic working environment
• Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner
• Experience with REDcap

Specific requirements by position classification are as follows:

CRC - Intermediate

• Bachelor's Degree in Health Science 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 orACRP prior to applying.)
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professionalfor qualifying experience prior to applying.)

CRC - Associate

• Bachelor's degree in Health Science 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 orACRP prior to applying.)

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

CRC - Technician

• Associate degree in Health Science or an equivalent combination of related education and experience is necessary.

• Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professionalfor qualifying experience prior to applying.)

or

• An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD.

or

• Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

Desired Qualifications*

CRC - Intermediate

• 6+ years of direct related experience

CRC- Associate

• 4+ years of direct related experience

CRC - Technician

Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable.

An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.

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.

This position is primarily onsite. Hybrid work schedule may be available after successful completion of training and demonstration of independent workload management. The work schedule will be determined based on operational needs including subject enrollment and study activity.

Work Schedule

The position is full-time. The work schedule will typically be Monday-Friday, 8-hour shifts. Potential evening and weekend coverage on a rotation basis, either on-site or remote, may be required to support study activities.

Underfill Statement

This position may be underfilled at the CRC-Associate or CRC-Technician titles based on selected candidates, qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

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 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.