Clinical Research Coord Inter/Assoc/Technician

Job Summary

The University of Michigan MATRIx team provides transcatheter (catheter-based) therapies for Mitral and Tricuspid valve disease. The MATRIx multidisciplinary team includes interventional cardiologist, cardiac surgeons, nurse practitioners, registered nurses, and clinical research coordinators.

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from one of the levels below (Intermediate, Associate, Technician) on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.

Responsibilities*

Characteristic Duties and Responsibilities:

Expert level knowledge, skills, and abilities within 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

Responsibilities will include, but are not limited to:

• Assists in quality control efforts to ensure work integrity.

• Assists with startup activities; contributing to the development of tools and processes to enhance the administration and execution of clinical studies.

• Assesses protocols and troubleshoots for potential implementation issues.

• Executes routine study management activities.

• Performs study procedures with accuracy.

• Triages complex study concerns appropriately.

• Schedules, assists with preparation, and attends study-related meetings.

• Manages increasing levels of protocol or study complexity and/or volume efficiently.

• Works with the research administration in the department and/or CTSU to appropriately manage subject visits and reconcile financial activity of study participants.

• Resolves complicated queries.

• Takes an active role in ensuring data quality.

• Understands Investigational product development processes and applies key regulatory requirements to control these processes.

• Accurately identifies and reports AEs, SAEs, and ORIOs

• Fulfills regulatory requirements related to use of devices used in studies and procures devices for inventory.

• Supervision Received:

• This position reports directly to the Clinical Research Manager for the Department of Cardiac Surgery. This position will have functional supervision by the Structural Heart Research Manager.

• Supervision Exercised:

• Could provide Functional supervision (likely in limited capacity such as training) of staff in titles within the CRC Career Ladder.

Required Qualifications*

Intermediate Level

• Bachelor's degree in health science or an equivalent combination of related education and experience is necessary.

• Certification is required through the Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or the 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