Clinical Research Coordinator Intermediate

4 days ago

Ann Arbor, Michigan, United States University of Michigan Full time
Clinical Research Coord Inter/Assoc/Technician

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.
Requirements:
  • 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.
Desired Qualifications:
  • 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.
Work Schedule:

40 hours/week, days, occasional evening, potential weekends.

Modes of Work:

Hybrid, full-time, regular.

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