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.

This clinical research coordinator (CRC) position may provide study coordination and/or project management for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties on the Michigan Medicine CRC Career Ladder is required. This position has achieved mastery in all aspects of clinical research management. This position has oversight for clinical research projects and has responsibility for ensuring that they are completed within specifications. This position establishes operational objectives and assignments and defines and manages project resource needs. Employees in this classification typically analyze, compare, and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision-making authority are predominantly performed independently affecting business operations to a substantial degree.

The Division of Pulmonary and Critical Care Medicine is seeking someone with significant experience in managing clinical trials and experience with NIH funded multi-site projects. The investigator works primarily within cystic fibrosis and bronchiectasis therapeutic areas so experience with pulmonary diseases and testing will be very helpful. This position will work closely with the Program Director to launch an NIH funded multi-site trial, where Michigan Medicine is the data coordinating and clinical coordinating center, by developing essential study documents, manuals, procedures, and onboarding sites by facilitating contracting, training etc. The study evaluates outcomes for patients randomized to two different standard-of-care treatments. Once the project is launched this position will be the primary point of contact for issues related to study operations and coordinate/manage bi-annual DSMB meetings. Other projects will include providing support for pharmaceutically sponsored trials by enrolling participants, conducting study visits, collecting data etc. 

This is a foundational position with a program poised for growth. As such, there will be significant opportunities to develop new skills, take on new responsibilities and projects, and grow professionally with the support and mentorship of the Program Director. It will be an excellent opportunity for an experienced individual who is a self-starter and wishes to grow in their career and be a partner in the growth of the program. This position does not currently have any direct reports, however, functional or administrative supervision of staff in the future is a possibility as program needs and funding permit, and depending on the skills, abilities, and desires of the candidate selected. 

Characteristic Duties and Responsibilities:

Set up unit wide systems or policies and manage a team of clinical research professionals (or portfolios) 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

Lead all aspects of an NIH sponsored multi-site investigator initiated trial encompassing 10-15 sites

• Develop all necessary essential study documents, tools, manuals, processes etc. 

  • Facilitate DSMB review for the project and participating sites

  • Serve as primary point of contact for study-related issues and needs 

  • Onboard participating sites by facilitating contract execution and registry access

  • Train participating sites in study related procedures and data collection

  • Manage data quality for participating sites

  • Liaise with biostats support regarding aims of project and analysis

  • Conduct project meetings that include participating sites

Support other sponsored trials by:

• Consenting and enrolling participants

  • Performing study visits

  • Collecting necessary data

  • Working with sponsors, CROs, and lab to ensure complete and accurate data collection, safeguard patient safety, and facilitate high quality study operations. 

Administrative duties:

• Working with and mentoring other CRCs supporting the program portfolio; functional or administrative supervision of staff in the future is a possibility.

  • Assisting with planning/scheduling program meetings as needed

  • Sit in on financial meetings and work to conceptually understand impact of financial decisions

  • Complete all necessary training required by institution, networks, sponsors etc. 

Other duties as assigned and/or agreed upon with Program Director

• CRC Governance Committee review and approval  
• Master'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 5 years (Senior/Lead) to 6 years (CRC-PM) 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.)  
   

• Project Management certification
• Experience with NIH funded trials
• Experience with multi-center investigator initiated trials 
• 9+ years of direct related experience

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

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

This position is hybrid, with at least 2-3 days/wk onsite work regularly in Ann Arbor, MI *required*. Work hours are Monday to Friday from 8:00 am to 5:00 p.m. There will be some travel to national meetings.

This position may be underfilled at the CRC-Lead or CRC-Senior titles based on selected candidates' qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

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

Supervision Exercised: None at this time

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 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 any time after the minimum posting period has ended.

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.