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:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. 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 or ACRP prior to applying.)
• Minimum of 3 years of directly related experience in clinical research and clinical trials is necessary at Intermediate level. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Associate Level

• 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 2 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)

Technician Level

• Associate degree in health science or an equivalent combination of related education and experience is necessary.
• ONE of the following:

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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 is desirable.
  An 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 is desirable.

Work Schedule

Hours/Week: 40 hours

Shift/Hours/Days: Days, occasional evening, potential weekends

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Additional Information

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

Background Screening

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Application Deadline

Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

Job Detail

Job Opening ID

243525

Working Title

Clinical Research Coord Inter/Assoc/Technician

Job Title

Clinical Research Coord Inter

Work Location

Ann Arbor Campus

Ann Arbor, MI

Full/Part Time

Full-Time

Regular/Temporary

Regular

FLSA Status

Exempt

Organizational Group

Medical School

Department

MM Cardiac Surgery

Posting Begin/End Date

5/14/2024 - 6/13/2024

Career Interest

Research