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Clinical Research Coord Intermediate

4 months ago

Ann Arbor, United States University of Michigan Health System Full time
How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Summary

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 the CRC-Associate position on the 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.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and 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. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?
  • Excellent medical, dental and vision coverage effective on your very first day
  • 2:1 Match on retirement savings


Responsibilities*

Contribute to the development of process and tools in 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

The successful applicant would be responsible for a variety of duties including but not limited to:
  • Review study protocols, assist in assessing feasibility, responsible for starting up studies including obtaining IRB approval, assisting in budget review, setting up study with all partnering departments including CTSU, MCRU, IDS, Radiology, Pathology and other departments as needed.
  • Responsible for regulatory compliance of all studies including IRB submission, maintenance, reporting of adverse events, maintenance of regulatory binders, interface with sponsors, CROs, central, and local IRB.
  • Review study protocols, develop screening algorithms, explain protocols to potential participants, plan and conduct study visits, collect and enter data, resolve data queries.
  • Supervise coordinators and students working in Dr. Lok's team.


Required Qualifications*

  • Bachelor's degree in Health Science or an equivalent combination of related education and experience.
  • 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 or )
  • Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's qualifying experience prior to applying.


Desired Qualifications*

  • 6+ years of direct related experience


Work Schedule

This is a full-time 40 hour/week onsite position.

Additional Information

Supervision Received: This position reports directly to Principal Investigator.

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

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.