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 for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder 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.

We are seeking a highly organized Clinical Research Coordinator Intermediate to manage the operational and regulatory execution of two single-center, FDA-regulated clinical trials. This role is designed for a professional who thrives in a systematic environment and values iterative process refinement. Initially, the candidate will work one-on-one with the Principal Investigator (PI) to ensure all research and regulatory activities are followed appropriately. Over time, the incumbent is expected to operate with a high degree of independence, making decisions of significance to ensure study integrity and operational efficiency.

The Principal Investigator has developed a robust framework of established systems designed to ensure that all research and regulatory activities are both automatic and systematic, minimizing the risk of oversight in high-stakes FDA trials. As the Clinical Research Coordinator Intermediate, you will initially engage with the PI daily,  collaborating closely to fine-tune these operations and ensure peak efficiency. This role is specifically designed with a trajectory for significant professional growth; as you master the existing systems, you will have the opportunity to transition into a position of high-level independence, making critical decisions that ensure study integrity. Furthermore, as the research portfolio expands, there is a clear pathway to develop and exercise team management skills, providing the opportunity to lead and mentor junior staff and coordinate larger organizational efforts as the team grows

• Study Execution & Clinical Activities: Executing day-to-day and time-sensitive SMART/ACUTE study protocol activities within their assigned window including subject recruitment, enrollment, medication administration and interacting with patients, providers, and PI
• Regulatory Compliance & Documentation:Lead all regulatory activities required to maintain FDA, IRB, and sponsor compliance. Maintain meticulous "audit-ready" documentation regarding participant enrollment, retention, and ongoing study activities. Ensure all research and regulatory activities are followed appropriately in close collaboration with the PI.
• Data Management: Responsible for the collection, entry, and quality control of clinical trial data. Maintain total data integrity across all electronic case report forms (eCRFs) and internal databases. Perform regular internal audits of data points to ensure accuracy and consistency without performing statistical analysis.
• Project Management & Meeting Facilitation: Maintain a high-level view of study progress to keep studies on track. Prepare for and lead organized, efficient study meetings, including drafting agendas, capturing actionable minutes, and tracking follow-up items. Manage project timelines and resource to meet milestones
• Protocol & Grant Development: Assisting PI with grant submissions (NIH/Industry); drafting protocol workflows

Characteristic Duties and Responsibilities:
Expert level knowledge, skills, and abilities within 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 a faculty PI

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

• 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)
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.

• Proven experience in clinical trial operations. While the trials are FDA-regulated, prior FDA-specific experience is preferred but not required; a strong foundation in clinical research is essential.
• High-level organization skills with a demonstrated ability to manage multiple moving parts systematically.
• Strong skills in running organized meetings and facilitating clear communication between the PI and the study team.
• Ability to work closely with a mentor/PI initially, with the professional maturity to gradually transition into an autonomous decision-maker.
• Comfortable working within established systems and databases to ensure no critical research activities are missed.

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 primarily onsite with option for hybrid when in hospital studied related activities are not required. Work typically occurs during normal business hours, 8 AM to 5 PM with options for flex time off if working outside of normal hours

This description is intended to indicate the kinds of tasks and levels of work difficulty that will be required of positions that will be given this title and shall not be construed as declaring what the specific duties and responsibilities of any particular position shall be. It is not intended to limit or in any way modify the right of any supervisor to assign, direct, and control the work of employees under his supervision. The use of a particular expression or illustration describing duties shall not be held to exclude other duties not mentioned that are of a similar kind or level of difficulty

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.