The posting will fill a Senior CRC position for a funded study beginning in April 2026, lasting five years, and with up to 30 clinical sites (outpatient dialysis centers) nationally. The University of Michigan is the Coordinating Center. The CRC will be responsible for activities at one of the Coordinating Centers hubs, the Clinical Coordinating Center (CCC), housed in the Department of Internal Medicine under the direction of the studys faculty PI. The CRC will ensure that the highest rigor is applied to study performance, including trial conduct, data integrity, and research subject protection. They will work with other team members to develop the protocol and study documents; contribute to processes and tools to support best practices; act as liaisons across study team members; run study meetings; and ensure adherence to the study budget. They will oversee and support the studys clinical sites, with the goal to promote successful recruitment, retention, and study conduct. They will support clinical site activities, including informed consent (obtained electronically), data entry, and data quality. They will support and monitor recruitment, retention, and protocol adherence; and oversee the studys participant engagement activities. Additionally, the CRC may serve as the site coordinator at UM as one of the studys clinical sites.
- Central Coordination of Study Operations-30%
- Ensure that the highest rigor is applied to study performance including trial conduct, data integrity, and research subject protection.
- Work with other team members to develop the protocol, Manual of Procedures, and all participant materials.
- Contribute to the development of processes and tools to support best practices associated with study execution.
- Acts as a point of contact and liaison between the study?s investigators, research teams, funder, and other stakeholders to get questions answered and issues resolved.
- Run regular study meetings
- Ensure adherence to study budget in support of the study PI and in collaboration with research administrators.
Central Clinical Coordination of Study Sites 30%
- Oversee and support the studys 20-30 clinical sites, with the goal to promote successful recruitment, retention, and study conduct.
- Support all start-up, implementation, and closeout activities at clinical sites.
- Support clinical sites as needed with informed consent (obtained electronically), data entry, and data quality.
- Support and monitor recruitment, retention, and protocol adherence.
Stakeholder Engagement- 20%
- Oversee patient/partner engagement across the study team and participating sites.
- Ensure adherence to the funders Foundational Expectations for Engagement.
- Develop and implement the engagement strategy.
- Coordinate with team leadership on integration of patient and caregiver perspectives, and troubleshoot site-level engagement challenges.
Site-level Study Coordination-10%
- Serve as lead site coordinator at UM as one of the studys clinical sites, responsible for recruitment of ten or more participants over two years and their retention over the study period.
Oversight of Assisting Coordinator- 10%
- Provide oversight and mentorship of the Assisting Coordinator in accomplishing the Clinical Research Coordinator teams scope of activities.
Contribute to the development of processes and tools 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
Supervision Received:
This position reports directly to the Faculty Principal Investigator
Supervision Exercised:
Could provide Functional supervision and /or administrative supervision of (1) more staff in the role of Clinical Research Assistant, Clinical Research Technician, CRC Associate, and CRC Intermediate