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PHN Clinical Research Coordinator Senior

University of Michigan

Job Description

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

A new Precision Health program focused on vascular diseases at the University of Michigan Medical School is seeking a highly motivated and experienced Clinical Research Coordinator to join our team. This is a multi-disciplinary collaboration across the medical campus and the primary appointment is in the Department of Internal Medicine, Division of Cardiovascular Medicine at Michigan Medicine/University of Michigan.  Importantly, the team, facilitated by the Coordinator Senior, will interface with extramural groups to develop and support a new multi-center consortium.  The selected individual will oversee regulatory activities for an existing registry/biorepository as well as for planned multi-site observational studies with potentially associated clinical trials.  S/he will also assist with coordinating all aspects of clinical research at Michigan Medicine including regulatory aspects, participant recruitment, consenting, clinic and research visit coordination, and coordination of data and sample collection in collaboration with the central laboratories supporting these activities, which intersect with the UM Central Biorepository and Michigan Genomics Initiative. Similar extension of this coordination to the multi-center initiative will be pursued.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally.  Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

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*

  • Prepare single-site and multi-site IRB applications; update and maintain IRB records including amendments and continuing reviews
  • Serve as the senior clinical research coordinator supporting the Michigan Medicine Precision Health Network
  • Train and coordinate activities of other team members involved in identifying, screening, and consenting participants from clinics and practice groups across Michigan Medicine
  • Coordinate the collection of blood, saliva, tissue, and other biological specimens
  • Work with the established team and pipeline for sample processing and tracking
  • Coordinate the collection of research data from patients and clinical staff, and through medical chart review
  • Follow up with participants as needed to obtain biological specimens, complete participant/family questionnaires, and clinic visit coordination
  • Participate in activities to streamline processes and enhance capabilities for recruiting, consenting participants and managing clinical research data
  • Communicate with the internal team as well as extramural collaborators and all stakeholders. and track regulatory aspects and collaborative benchmarks
  • Generate regular progress reports for regularly occurring study coordination meetings, consortium meetings, and funding applications and reports
  • Track budgetary aspects of the above
  • Responsibilities for this position may evolve to match changing needs and priorities

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

Supervision Received: This position reports directly to the Faculty Principal Investigator.

Supervision Exercised: None

Required Qualifications*

  • CRC Governance Committee review and approval
  • 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) and must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire.
  • Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.
  • Strong interpersonal and written communication skills
  • Flexibility and ability to work independently and collaboratively with researchers, faculty, patients, and families in a dynamic work environment in a diplomatic and effective manner
  • Excellent organizational skills including the ability to work well under time constraints to meet deadlines
  • Excellent computer skills including proficiency in Microsoft software applications (Word, Excel, PowerPoint)

Desired Qualifications*

  • 9+ years of direct related experience
  • Experience with the U-M eResearch Regulatory Management and Proposal Management systems, MiChart, REDCap, LabVantage
  • Experience coordinating multi-center investigator-initiated clinical research
  • Experience with handling/tracking/accessing biological sample

Work Schedule

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

Underfill Statement

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.

Additional Information

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. 
 

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.


U-M COVID-19 Vaccination Policy

COVID-19 vaccinations, including one booster when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely and temporary workers.   More information on this new policy is available on the U-M Health Response website or the UM-Dearborn and UM-Flint websites.

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