Clinical Research Coordinator Associate
About the Role
This position provides study coordination for multiple clinical research studies, ranging from moderate to complex. The role requires coordinator experience and mastery of all job duties from the Clinical Research Technician position. The ideal candidate will perform tasks and make decisions independently, consistently, and accurately, demonstrating a moderate level of expertise across a broad range of clinical studies. Proficiency in navigating resources, using tools and job aids, and operating e-clinical technologies is expected.
Responsibilities
- Clinical Coordinator Responsibilities (50%):
- Performs non-GCP related study management activities
- Performs study procedures with minimal supervision
- Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits
- Regulatory Coordinator Responsibilities (10%):
- Form completion and reporting to external governing bodies such as the FDA
- Demonstrates an understanding of subject safety, related documentation, and reporting
- Data Coordinator Responsibilities (20%):
- Enters data to complete forms
- Training (10%):
- Completes required training such as PEERRS, HIPAA, and CITI GCP
- Administrative Responsibilities (10%):
- Creates documentation materials for studies
Independent knowledge, skills, and abilities are expected across all 8 competency domains:
- 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
Requirements
- Bachelor’s degree in Health Science or an equivalent combination of related education and experience
- Certification through the 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 Professional (CCRP) or equivalent. Candidates must be eligible to register or take the exam at the date of hire, with certification completed within six months of hire.
- Minimum of 2 years of directly related experience in clinical research and clinical trials
Why Join Michigan Medicine?
Michigan Medicine is one of the largest health care complexes in the world, with a history of groundbreaking medical and technological advancements since 1850. Comprising over 30,000 employees, 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.
Benefits
- Excellent medical, dental, and vision coverage effective on your very first day
- 2:1 match on retirement savings
Hybrid or mobile/remote work modes may be available at the discretion of the hiring department. Work agreements are reviewed annually and are subject to change.