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 and/or CRC-Senior position on the Michigan Medicine CRC Career Ladder is required. This position demonstrates the ability to lead study team members in the implementation of study related activities. This position develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on the work of others. 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, lead, guide, mentor, and support.

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.

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

Characteristic Duties and Responsibilities:

Contribute to the development of process/tools and lead others 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

Clinical Coordinator Responsibilities 

• Develops tools, processes, and training to enhance the administration and execution of clinical trials.
• Designs processes and tools to assess study execution and leads team on accurate implementation of protocol.
• Develops processes, tools, and training to support the non-GCP-related activities associated with study execution.
• Performs study procedures at the highest levels and mentors team members in accurate completion of study procedures.
• Develops processes and tools, and mentors study team in best practices for addressing subject concerns efficiently.

Data Coordinator Responsibilities

• Oversees data quality.
• Performs at the highest level of data management and results reporting.

Regulatory Coordinator Responsibilities 

• Develop processes, tools, and training to enhance site compliance with the requirements necessary for the safe and effective development of investigational products.
• Monitors site compliance with subject safety reporting, escalate issues, and develops tools, processes, and training to enhance subject safety during the conduct of a clinical study

Administrative Responsibilities 

• Leads a team of coordinators in support of clinical research.
• Functional supervision of clinical research staff and temporary staff.
• Demonstrates professionalism and applies well-developed leadership practices in all aspects of the role of the CRC.
• Oversees study conducted by staff and guides quality assurance efforts.
• Responsible for recommendations on workload assessments and distribution.
• Develops processes, tools, and training to support the GCP-related activities associated with study execution.

Training 

• All training requirements of previous level.
• Develops and conducts training for staff and others.
• Other duties as assigned.

Senior Requirements:

• 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. 
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary. 

Intermediate Requirements:

• 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 SoC

• Masters Degree in Health Science or an equivalent combination of related education and related experience is desirable. 
• 9+ years of direct related experience
• Experience in data entry and monitoring, including the use of Excel and Redcap

Hybrid position with time split between Taubman outpatient pulmonary clinic, MSRB3 laboratory and home. In-person work includes recruitment of patients into the UM ILD biobank and cohort studies on Mondays, Tuesdays and Fridays. Wednesdays and Thursdays are typically work from home and reserved for data entry and administrative duties. Administrative duties primarily focus on IRB submissions, interactions with sponsors and study visit planning for cohort studies. 

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

This position may be underfilled at the CRC-Senior or CRC-Intermediate 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 Justin Oldham, MD PhD.

Supervision Exercised: Provides functional supervision of 2-3 FTE within the CRC Career Ladder and temp staff as needed.

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 anytime after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.