Clinical Research Coord Assoc

Emergency Medicine is looking for an experienced Clinical Research Coordinator to assist with multiple study projects within the Emergency Department. The candidate will support all aspects of clinical research, including study planning, IRB management, patient identification, consenting, enrollment, lab procedures, and data collection.

About the role

This position may independently coordinate simple to moderately complex clinical research studies. As part of a coordination team, the role supports a portfolio of projects with varying complexity. Mastery of all duties from the CRC-Technician level on the Michigan Medicine CRC Career Ladder is required.

Responsibilities

• Demonstrate independent knowledge, skills, and abilities across all 8 competency domains:
  • 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 all aspects of research regulatory compliance, including preparation and submission of IRB protocols (initial applications, amendments, continuing reviews, progress reports, safety reports, adverse event reports).
• Create and maintain study standard operating procedures, protocols, and research binders.
• Perform literature reviews and complete study tracking documentation accurately and timely.
• Develop and update project tracking systems.
• Communicate with investigators and study staff to ensure alignment with research protocols and regulatory requirements.
• Coordinate all aspects of research study operations:
  • Identify and pre-screen potential subjects to ensure inclusion criteria are met.
  • Screen, consent, and enroll participants using various methods.
  • Conduct interviews, collect clinical and demographic data, and perform follow-up assessments.
  • Coordinate specimen collection and storage.
  • Monitor subjects for safety and protocol compliance.
  • Manage daily study operations.
• Develop, design, and conduct small to moderately complex research projects; review progress and evaluate results.
• Formulate research methods, suggest quality improvements, identify potential problems, and implement solutions.
• Consult with study staff to refine or adapt methodologies to fit research goals.
• Collaborate in developing new techniques, procedures, and protocols.
• Work independently and as part of a team, exercising good judgment in setting priorities and resolving operational issues.
• Maintain strict confidentiality and participate actively in research meetings.
• Cover evening and weekend shifts as required by the nature of emergency department patient care.
• Cross-train with other staff and perform additional work-related tasks as needed.

Requirements

• Bachelor’s degree in health science or other relevant science, or an equivalent combination of related education and experience.
• Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
• Organized, efficient, self-motivated, and proficient in computer skills, including Microsoft software applications.
• Ability to manage multiple tasks/projects simultaneously, prioritize, and exercise good judgment.
• Ability to work independently with minimal supervision while collaborating effectively with a diverse team.
• Comfortable working in the Emergency Department, interacting with diverse populations, and discussing sensitive topics with participants and families.

Qualifications

One of the following qualification sets is required:

• Associate Bachelor’s Degree Path:
  • Bachelor’s degree in Health Science or equivalent combination of education and experience.
  • Certification through ACRP (CCRC) or SOCRA (CCRP) or equivalent. Must be eligible to register or take the exam at hire and complete certification within six months.
  • Minimum 2 years of directly related experience in clinical research and clinical trials. Review SoCRA’s Definition of a Clinical Research Professional for qualifying experience.
• Technician Path:
  • Associate degree in Health Science or equivalent combination of 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 for qualifying experience.
    • Advanced degree in a health-related field (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, clinical information, and research.

Desired Qualifications

• Previous clinical research experience, clinic/hospital/lab work, or volunteer experience.
• Knowledge of research protocols and processes.
• Ability to work collaboratively and independently with limited supervision after onboarding.
• Familiarity with Epic, MiChart, eResearch applications, PEERS, and IRB review processes.
• Experience with REDCap, Qualtrics, or similar data capturing systems.

Benefits

• Excellent medical, dental, and vision coverage effective on the first day of employment.
• 2:1 match on retirement savings.
• Hybrid or mobile/remote work options may be available at the discretion of the hiring department.

Schedule

• Onsite for 8-hour shifts, 40 hours per week.
• Routine evening and weekend shifts required due to the nature of emergency department patient care.

This position reports directly to the Program Manager for the Traumatic Brain Injury Program. Background screening and pre-employment drug testing are required for selected candidates.