Michigan Medicine ยท 15 hours ago
Clinical Research Coordinator Senior underfill Clinical Research Coordinator Intermediate
Ann Arbor, MI
Full-time
Hybrid
Mid, Senior Level
3+ years expMichigan Medicine is one of the largest health care complexes in the world, and they are seeking a Clinical Research Coordinator Senior to provide study coordination for multiple clinical research studies. This role involves leading study team members, developing processes and training, and ensuring compliance with safety and regulatory standards.
EducationHealth CareMedical
Responsibilities
Contribute to the development of process/tools and lead others 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
Develops tools, processes, and training to enhance the administration and execution of clinical trials
Designs processes and tools to assess study execution and leads team on accurate implementation of protocol
Develops processes, tools, and training to support the non-GCP-related activities associated with study execution
Performs study procedures at the highest levels and mentors team members in accurate completion of study procedures
Develops processes and tools, and mentors study team in best practices for addressing subject concerns efficiently
Oversees data quality
Performs at the highest level of data management and results reporting
Develop processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products
Monitors site compliance with subject safety reporting, escalate issues, and develops tools, processes, and training to enhance subject safety during the conduct of a clinical study
Leads a team of coordinators in support of clinical research
Functional supervision of clinical research staff and temporary staff
Demonstrates professionalism and applies well-developed leadership practices in all aspects of the role of the CRC
Oversees study conducted by staff and guides quality assurance efforts
Responsible for recommendations on workload assessments and distribution
Develops processes, tools, and training to support the GCP-related activities associated with study execution
Develops and conducts training for staff and others
Other duties as assigned
Qualification
Required
CRC Governance Committee review and approval
Bachelors 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
Minimum 5 years of directly related experience in clinical research and clinical trials is necessary
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 or ACRP prior to applying.)
Minimum 3 years of directly related experience in clinical research and clinical trials is necessary
Preferred
Masters Degree in Health Science or an equivalent combination of related education and related experience is desirable
9+ years of direct related experience
Experience in data entry and monitoring, including the use of Excel and Redcap
Benefits
Excellent medical, dental and vision coverage effective on your very first day
2:1 Match on retirement savings
Company
Michigan Medicine
Michigan Medicine is a health care system and academic medical center that provides medical education and more. It is a sub-organization of University of Maichigan.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Ascani
Director, Business Operations - Applied Systems Biology Core
Jack Kufahl
Chief Information Security Officer
Recent News
2025-12-11
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