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:
- 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 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.
