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Job Description
The Pediatric Emergency Medicine (PEM) research program is seeking an experienced and highly motivated Clinical Research Coordinator to serve as a divisional research lead supporting a diverse portfolio of pediatric emergency medicine studies. This position functions as CRC-Lead for the PEM research team, providing day to day oversight of research activities, staff coordination, regulatory compliance, and study operations in a fast-paced clinical environment. The selected candidate will receive comprehensive training on all active and new Pediatric Emergency Medicine research studies and is expected to be fully cross?trained to support and enroll participants in all ongoing research protocols. This role requires maintaining broad study knowledge to ensure consistent coverage, high?quality enrollment, and continuity of research operations across the program. This role is integral to maintaining the PEM research program as a core component of patient care, education, and discovery. This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.
Characteristic Duties and Responsibilities:
Experience as part of a team with all 8 competency domains is expected: Scientific Concepts and Research Design Ethical Participant Safety Considerations Investigational Products Development and Regulation Clinical Study Operations (GCPs) Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork Manage day-to-day operations of pediatric emergency medicine research studies, including interventional and non-interventional protocols. Monitor study progress, enrollment targets, timelines, and deliverables; identify challenges and implement solutions. Ensure adherence to study protocols, institutional policies, Good Clinical Practice (GCP), and human subjects protections. Oversee regulatory submissions and ongoing maintenance with Institutional Review Boards (IRBs) and other oversight bodies. Oversee data collection, entry, quality assurance, and query resolution. Coordinate with data coordinating centers, sponsors, and biostatistical teams as applicable. Associate degree in Health Science or an equivalent combination of related education and experience is necessary. Minimum 1 year 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.) or An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. or Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research. Demonstrated knowledge of human subjects research, clinical study operations, and regulatory requirements. Strong organizational, communication, and problem solving skills. Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable. An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable. Experience working in pediatric or emergency medicine research. Prior experience coordinating multiple studies and/or leading research teams. Knowledge of IRB processes, GCP guidelines, and research data systems. Ability to manage competing priorities in a fast-paced clinical environment. Experience mentoring or training research staff, students, or trainees.
Supervision Received:
This position receives direct supervision and reports directly to Pediatric Emergency Medicine research faculty and administrative leadership within Emergency Medicine Research.
Supervision Exercised:
This position provides functional supervision and operational direction to research staff and trainees. This may include coordinating schedules, assigning work, monitoring performance, and contributing to staff training and development. 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. 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. 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 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.
