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Clinical Research Coordinator Intermediate
4 weeks ago
Join the University of Michigan MATRIx team as a Clinical Research Coordinator Intermediate, Associate, or Technician and contribute to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains.
Key Responsibilities:- Assist in quality control efforts to ensure work integrity.
- Assist with startup activities; contributing to the development of tools and processes to enhance the administration and execution of clinical studies.
- Assess protocols and troubleshoot for potential implementation issues.
- Execute routine study management activities.
- Perform study procedures with accuracy.
- Triage complex study concerns appropriately.
- Schedule, assist with preparation, and attend study-related meetings.
- Manage increasing levels of protocol or study complexity and/or volume efficiently.
- Work with the research administration in the department and/or CTSU to appropriately manage subject visits and reconcile financial activity of study participants.
- Resolve complicated queries.
- Take an active role in ensuring data quality.
- Understand Investigational product development processes and apply key regulatory requirements to control these processes.
- Accurately identify and report AEs, SAEs, and ORIOs.
- Fulfill regulatory requirements related to use of devices used in studies and procure devices for inventory.
- Intermediate Level: Bachelor's degree in health science or an equivalent combination of related education and experience.
- Associate Level: Bachelor's degree in Health Science or an equivalent combination of related education and experience.
- Technician Level: Associate degree in health science or an equivalent combination of related education and experience.
- Intermediate Level: 6+ years of directly-related experience, experience working in a medical device or regulated industry, experience with electronic data capture, knowledge of cardiovascular physiology and structural heart anatomy.
- Associate Level: 4+ years of direct related experience.
- Technician Level: Bachelor's degree in Health Science or an equivalent combination of related education and experience, understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures.
40 hours/week, days, occasional evening, potential weekends.
Modes of Work:Hybrid, full-time, regular.
