Clinical Research Coordinator Senior

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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 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. Coordinator experience and mastery of all job duties on the Michigan Medicine CRC Career Ladder is required.  This position will provide leadership in the day-to-day implementation and coordination of complex clinical research activities, ensuring studies are conducted in accordance with protocols, Good Clinical Practice (GCP), institutional policies, and applicable regulatory requirements.

The CRC Lead will work closely with PCCM Project Managers and Principal Investigators, multidisciplinary clinical partners, internal and external study teams, and other stakeholders to ensure high-quality and efficient execution of the PCCM clinical research portfolio. The Clinical Research Coordinator will also serve as the regulatory lead for a UG3-funded, multi-center research consortium that will establish a harmonized U.S. cohort of children hospitalized with viral lower respiratory tract infections across nine sites and follow participants over a period of time.

In this role, the CRC Lead will coordinate and oversee regulatory activities, support harmonization of regulatory processes across participating sites, and work closely with the Principal Investigator, study leadership, and participating research teams to ensure compliance with applicable regulatory and study requirements.

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 Clinical Research Coordination and Study Leadership Serve as a lead clinical research coordinator for federally funded and investigator-initiated research clinical research studies

Coordinate and oversee the day-to-day implementation of study protocols, ensuring adherence to protocol requirements, GCP, institutional policies, and applicable regulatory requirements.

Develop and implement processes, tools, and workflows to support efficient and consistent study execution.

Coordinate study activities across investigators, research staff, clinical teams, participants, and other internal and external stakeholders.

Perform study procedures and clinical research activities at an advanced level and serve as a resource to other members of the study team.

Identify operational challenges and develop solutions to improve study efficiency, participant experience, and data quality.

Monitor study progress, timelines, enrollment, and other key study metrics and communicate updates and concerns to the appropriate leadership.

Assist with…