Clinical Research Coord Senior/Intermediate

Posted: 18-Mar-24

Location: Ann Arbor, Michigan

Salary: Open

Categories:

Staff/Administrative

Internal Number: 244935

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.

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-Intermediate position on the Michigan Medicine CRC Career Ladder is required, including experience with various committees at the University. This position gives back to the institution through mentoring others on study management and participating in training and development of junior clinical research professionals.  This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This level of CRC develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. This position 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, develop, evaluate, guide, mentor, and support.

Contribute to the development of process and tools in all 8 competency domains is expected:

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.
• Lead, train and supervise coordinators and students working in Dr. Lok’s team which include staff working with Dr. Lok’s faculty mentees.
• Supervise LOK Lab which is used by several hepatology faculty team for sample processing and temporary storage – verify training of all users, ensure compliance and safety.
• Review study protocols, develop screening algorithms, explain protocols to potential participants, plan and conduct study visits, collect and enter data, resolve data queries.

Supervision Received: This position reports directly to Principal Investigator.

Supervision Exercised: Will train and oversee activities of other staff in titles within the CRC Career Ladder.

Clinical Research Coordinator Senior: 

• CRC Governance Committee review and approval
• Bachelors 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 5 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.)  

Clinical Research Coordinator Intermediate: 

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

Clinical Research Coordinator Senior: 

• 9+ years of direct related experience

Clinical Research Coordinator Intermediate:

• 6+ years of direct related experience

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

This position may be underfilled at the CRC-Intermediate title based on selected candidates qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

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. 

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.

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.

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

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About University of Michigan – Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its “Great Colleges to Work For” survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.
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