Clinical Research Coord Assoc

Mission Statement: 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.

About the role

This position will serve as a Clinical Research Coordinator Associate in the Oncology Clinical Trial Support Unit (O-CTSU) - Clinic Research Group located in the Brighton Center for Specialty Care, providing study coordination support to faculty and research teams for the University of Michigan Rogel Cancer Center—an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN).

The Rogel Cancer Center is among the top-ranked national programs in research and patient care, with members holding $120M in annual direct research funding. Its mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration.

Within the Oncology CTSU, you will join a diverse team of 175 clinical research professionals dedicated to advancing this mission through cutting-edge early phase trials to practice-changing phase III studies. The team invests in education, training, career development, and certification, offering specialized roles and growth opportunities to fit your desired career path and goals.

This Clinical Research Coordinator (CRC) position may provide study coordination for multiple clinical research studies, ranging 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 requires independent task performance, decision-making, and a moderate level of expertise in skills and abilities, resulting in high-quality work. The position applies skills across a broad range of clinical studies, navigates resources effectively, and uses e-clinical technologies proficiently.

Due to the complex nature of Oncology Clinical Trials, a team of clinical research coordinators specializing in data management, regulatory, or clinic coordination collaborates to cover all aspects of the role. This posting is for a Clinic specialization, located at the Brighton Center for Specialty Care (BCSC) in Brighton. Occasional travel to the Ann Arbor location may be required for training or support.

Responsibilities

• Clinical Research Coordinator - Associate:
  • Demonstrates understanding of protocol elements/requirements and executes study procedures.
  • Anticipates and mitigates potential for protocol non-compliance.
  • Describes protocol structure and interprets study requirements to ensure compliance.
  • Accurately implements protocol procedures.
  • Performs non-GCP-related study management activities.
  • Executes study procedures with minimal supervision.
  • Triages simple subject issues appropriately.
  • Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
  • Comfortable with basic clinical lab equipment (e.g., centrifuge, freezers, pipettes) and standard laboratory safety guidelines.
  • Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies and subject visit billing.
  • Responsible for research sample processing.
• Clinical Research Coordinator - Technician:
  • Independently provides study coordination for simple and moderately complex clinical research studies.
  • Supports a portfolio of projects with varying levels of complexity as part of a coordination team.
  • Performs moderately complex study procedures with accuracy.
  • Triages simple subject concerns appropriately.
  • Assesses studies for execution and troubleshoots potential implementation issues.
  • Completes simple to moderately complex data collection during study visits.
  • May reconcile financial accounts for study participants with CTSUs.
  • Assists with local quality control efforts.
  • Responsible for research sample processing.
• Clinical Research Assistant:
  • Provides assistance for multiple clinical research studies.
  • Performs tasks and makes decisions independently, consistently, and accurately.
  • Applies skills to a broad range of tasks and navigates resources effectively.
  • Identifies appropriate resources and support, escalating issues as needed.

Independent knowledge, skills, and abilities within all 8 competency domains are 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

Requirements

• Clinical Research Coordinator - Associate:
  • Bachelor's Degree in Health Science or equivalent combined education and clinical research experience.
  • Certification 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 Professional (CCRP) or equivalent.
  • Minimum 2 years of directly related experience in clinical research and clinical trials. Review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
• Clinical Research Coordinator - Technician:
  • Associate Degree in Health Science or an equivalent combination of related education and experience.
  • One of the following:
    • Minimum 1 year of directly related experience in clinical research and clinical trials. Review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
    • An advanced degree in a health-related area (e.g., Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD).
    • Minimum 3 years of human subject experience (clinical, lab, or health regulations), such as related patient care, community health and wellness, clinical information, and research.
• Clinical Research Assistant:
  • High School Diploma or GED.

Qualifications

• Clinical Research Coordinator - Associate:
  • 4+ years of directly related experience.
• Clinical Research Coordinator - Technician:
  • Bachelor's Degree; Health Science field preferred or related certification.
  • Understanding of medical terminology.
  • Experience in a large, complex healthcare setting.
  • Ability to effectively communicate with staff and faculty of all levels.
  • Knowledge of University policies and procedures.
• Clinical Research Assistant:
  • Bachelor's Degree; Health Science field preferred or related certification.
  • Understanding of medical terminology.
  • Experience in a large, complex healthcare setting.
  • Ability to effectively communicate with staff and faculty of all levels.
  • Knowledge of University policies and procedures.

Benefits

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

Schedule

• Monday through Friday, core business hours.
• Occasional evening or weekend work to meet deadlines or support patient care.

Positions eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually and may change at any time.

This position may be underfilled at the CRC-Technician title based on selected candidates' qualifications.