"Clinical Research Coord Assoc"

Job Summary

Emergency Medicine is looking for an experienced Clinical Research Coordinator to assist with multiple study projects within the Traumatic Brain Injury Program. The candidate will assist with multiple study projects, in all aspects of clinical research including study planning and start-up, IRB management, identifying study patients, consenting and enrolling participants, lab procedures, as well as data collection. 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.

Independent 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

Responsibilities

• Responsible for all aspects of research regulatory compliance, such as preparation/writing of IRB protocols for submission and maintenance (including the initial applications, amendments, scheduled continuing reviews, progress reports, safety reports, adverse event reports, etc.), while ensuring effective routine communication with the IRB. Create and maintain study standard operating procedures/protocols and research binders. Perform literature reviews. Completion of study tracking documentation accurately and in a timely manner. Create and routinely update project tracking systems. Communicate and consult with investigators and study staff to ensure alignment with research protocols and regulatory requirements.
• Responsible for all aspects of research study coordination: Identifying/pre-screening potential subject records to ensure they meet study inclusion criteria, screening potential subjects, consenting and enrollment (using a variety of methods), interviewing subjects, collecting relevant clinical and demographic data, and conducting phone call follow-up assessments. Coordination of specimen collection and storage. Monitor subjects for safety and compliance with protocols. Coordination/management of all daily study operations.
• May develop, design, and conduct one or more small or moderately complex research projects according to plan; reviews progress and evaluate results. Formulates research methods and suggests options for improving quality, identifies potential problems, recommends, and implements solutions. Consults with study staff to refine or adapt methodologies to fit research goals and specific aims. Collaborates in development of new techniques and procedures/protocols.
• Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality. Regular active participation in research meetings will be expected.
• This position will assist with research studies within the Michigan Medicine Department of Emergency Medicine. Due to the nature of our patient care, this position will routinely require covering some evening and weekend shifts. Cross training with other staff will be required.
• Additional work-related tasks, not specifically outlined above, will be required of the candidate.

Supervision

Supervision Received: This position reports directly to the Program Manager for the Traumatic Brain Injury Program.

Supervision Exercised: none

Required Qualifications

General:

• Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
• Must be organized, efficient, self-motivated, and proficient in computer skills including Microsoft software applications.
• Ability to organize and manage multiple tasks/projects simultaneously, as well as prioritize and exercise good judgment.
• Ability to work independently with minimal supervision while maintaining effective collaborations and communication with a diverse team of individuals in a diplomatic, professional, collaborative, and effective manner.
• Candidate will be expected to prioritize multiple tasks, meet deadlines, and adhere to strict confidentiality policies.
• Must be comfortable working in the Emergency Department (following established protocols to facilitate social distancing and reduce COVID-19 transmission risks), interacting with diverse populations, and potentially discussing sensitive topics with study participants and families.

Associate:

• Bachelor's degree in Health Science or an equivalent combination of related education and experience.
• 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 within six months of date of hire. (SoCRA or ACRP)
• Minimum 2 years of directly related experience in clinical research and clinical trials is necessary.

Technician:

• Associate degree in Health Science or an equivalent combination of related education and experience.
• ONE of the following: Minimum 1 years of directly related experience in clinical research and clinical trials; or An advanced degree in a health-related areas; or Minimum 3 years of human subject experience.

Assistant:

• High school diploma or GED is necessary.
• Previous clinical research experience, clinic/hospital/lab work or volunteer experience, and knowledge of the research protocols and processes are highly desired.

Desired: The ideal candidate for this position will be able to work as a member of a collaborative team but have the ability to function independently with limited supervision after a period of on-boarding. Familiarity and experience with Epic, MiChart and eResearch applications. PEERS, regulatory compliance, IRB review and approval process. Experience with REDCap (Research Electronic Data Capture), Qualtrics or a similar data capturing system.

This position will assist with research studies within the Michigan Medicine Department of Emergency Medicine. Due to the nature of our patient care, this position will be onsite for 8-hour shifts for 40 hours a week, and routine evening and weekend shifts will be required. This position may be underfilled at the CRC-Technician or CRC-Assistant titles based on selected candidates' qualifications.

Posted: 24-Dec-25

Location: Ann Arbor, Michigan

Categories: Staff/Administrative

Internal Number: 269695