Clinical Research Coordinator - Assistant

Job Summary

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. The role should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate a moderate level of expertise in all skills and abilities resulting in high quality work.

The position can perform the majority of tasks independently and perform quality checks of their work, identify appropriate resources and support, and discern when to elevate issues needing additional intervention.

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.

• Excellent medical, dental and vision coverage effective on your very first day
• 2:1 Match on retirement savings

• 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

• Perform study procedures with minimal supervision
• Schedule and assist with preparation for, attend study initiation meetings, monitor visits, and audits
• Ensure integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.)
• Demonstrate understanding of protocol elements/requirements and execute study procedures
• Anticipate and mitigate potential for protocol non‑compliance
• Explain study procedures and protocol requirements to study staff and participants
• Triage simple subject concerns and issues appropriately
• Work with basic clinical lab equipment and maintain laboratory safety
• Explain the role of the Clinical Trial Support Unit (CTSU) for study initiation and billing

• Document data in accordance with ALCOA‑C principles
• Utilize information from the EMR and study databases for data collection
• Complete complex data collection during study visits
• Resolve data queries efficiently

• Perform study operational activities in compliance with Good Clinical Practice (GCP)
• Document as outlined in ICH‑GCP guidelines
• Distinguish and report Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs)
• Collaborate with the Office of Research Compliance Review to post studies on Clinical Trials.gov
• Assist with Investigator Initiated studies and maintain regulatory documents
• Support regulatory submissions and renewals

• Support study activity including management of subject reimbursement and payments
• Assist with creating posters, abstracts, and articles
• Participate in regular study meetings and complete payment forms

• Complete training for Clinical Research Professional certification
• Complete required trainings: PEERRS, HIPAA, CITI GCP, eRPM…