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.

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 has achieved mastery in all aspects of clinical research management. This position has oversight for clinical research projects and has responsibility for ensuring that they are completed within specifications. This position establishes operational objectives and assignments and defines and manages project resource needs including project staff. Employees in this classification typically analyze, compare, and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision-making authority are predominantly performed independently affecting business operations to a substantial degree.

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:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

This position serves as a Clinical Research Coordinator in the Pediatric Critical Care Medicine Division (PCCM/PICU) at the University of Michigan C.S. Mott Children?s Hospital, The coordinator provides study coordination, specimen collection, and data management support to faculty and research teams. The division is recognized for expertise in respiratory distress, ECMO, and sepsis affecting pediatric and young adult populations, and participates in national clinical trials networks such as the Collaborative Pediatric Critical Care Research Network (CPCCRN). 
 

The coordinator may independently manage multiple moderately complex clinical research studies or support a portfolio of studies as part of a team. Responsibilities include applying critical thinking and problem-solving skills to support study execution, contributing to processes improvement efforts, and performing quality assurance activities in alignment with institutional and regulatory standards.
 

Key responsibilities include:

• Screen, recruit, consent, and monitor research participants in accordance with study protocols  
• Coordinates study visits and follow-up activities
• Collect, process, store, ship and track research specimens, ensuring integrity and compliance with protocol and regulatory requirements
• Maintain accurate source documentation and study data; perform quality assurance/quality control activities
• Collaborate with multidisciplinary teams including clinicians, nurses, research pharmacy, and administrative staff to ensure protocol adherence and resolve issues
• Identify and troubleshoot study-related, participant, and workflow challenges
• Report and route adverse events (AEs/SAEs) in in accordance with institutional, sponsor, and regulatory requirements 
• Support multiple concurrent studies, prioritizing tasks and timelines effectively 
• Assist with IRB regulatory processes including study start-up, amendments, continuing reviews, and safety reporting 
• Communicate with sponsors and CTSU regarding study progress, recruitment, and operational considerations
• Serve as a liaison between study teams, sponsors, IRB, and regulatory agencies 
• Participate in investigator and scientific meetings as needed
   

Supervision Received:
This position reports to the Clinical Research Project Manager and works closely with the division?s Research Director.  Indirect report includes the Division Administrator and the Division Director/PI.  The role requires strong organizational, analytical, critical thinking, problem-solving, and interpersonal skills, along with the ability to work both independently and collaboratively.

Supervision Exercised:

This position manages a portfolio of multi-site clinical research as assigned.

• 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 is required

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. 
   

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. 

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

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.

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

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.

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.

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.

The University of Michigan is an equal employment opportunity employer.