Job Description
Overview
Join our growing Clinical Trials Unit (CTU) in Plymouth, MI, where we conduct innovative, high-impact clinical trials across expanding therapeutic areas. Since 2014, our collaborative team has thrived in a fast-paced environment focused on accuracy, participant safety, and operational excellence. We anticipate continued growth and offer opportunities for advancement to skilled Clinical Research Coordinators.
This is a full-time position; however, part-time scheduling may be considered for highly qualified candidates. While most work will require on-site presence, there is opportunity to work 1 day remote dependent on project needs. Most shifts occur during daytime hours, though occasional evening, overnight, or weekend coverage may be required depending on study needs.
Job Summary
The Clinical Research Coordinator III (CRC III) is an advanced-level role responsible for independently coordinating complex clinical research studies from startup through closeout. This position requires strong clinical research knowledge, clinical trial experience, advanced protocol management skills, and the ability to support multiple studies simultaneously. The CRC III plays a critical role in participant recruitment, enrollment, visit execution, data management, and biospecimen handling while ensuring compliance with ICH-GCP, FDA, and sponsor requirements. The CRC III may also support regulatory submissions and serve as a resource to junior staff.
Responsibilities - Actively participates in participant recruitment, screening, informed consent, and enrollment.
- Coordinates complex study visits and procedures in accordance with protocol requirements.
- Oversees accurate data collection, source documentation, and entry into EDC systems.
- Performs data cleaning and resolves queries within sponsor-required timelines.
- Collects, processes, labels, stores, and ships biospecimens per laboratory manual specifications.
- Monitors participant safety, clinical status, and adverse events; ensures timely reporting.
- Ensures compliance with ICH-GCP, FDA, OHRP, HIPAA, and sponsor requirements.
- Manages regulatory components of studies, including maintaining the electronic Investigator Site File (eISF).
- Prepares for and participates in monitoring visits, SIVs, SQVs, and closeout visits.
- Provides mentorship and guidance to CRC I and CRC II team members.
- Participates in team meetings, investigator meetings, and sponsor-required trainings.
- Collaborates with investigators, clinicians, and research staff to support study execution.
- Assists in developing recruitment materials, source documents, and study tools.
- Maintains awareness of industry best practices and evolving research regulations.
Qualifications Required Qualifications - Bachelor's degree in health science, medical, or related discipline.
- 4-6 years of experience working with commercial clinical trials.
- BLS and/or ACLS certification.
- Proficiency with Microsoft Office and common EDC systems.
- Strong understanding of ICH-GCP, FDA, OHRP, and HIPAA regulations.
- Experience with biospecimen collection, processing, and shipping.
- Excellent organizational and problem-solving skills with ability to manage multiple studies.
- Strong communication and leadership ability.
- Ability to maintain strict confidentiality and data security.
- U.S. Citizenship or Permanent Residency required.
Preferred Qualifications - ACRP-CCRC or SOCRA certification.
- Extensive knowledge of medical terminology, clinical lab assessments, and pharmacovigilance.
- Experience with IRB processes and regulatory submission platforms (e.g., ePortal).
Candidate Traits - Highly detail-oriented with exceptional organizational skills.
- Strong leadership abilities with experience mentoring junior staff.
- Proactive problem solver with ability to work in a dynamic environment.
- Strong interpersonal skills and ability to collaborate with cross-disciplinary teams.
- Self-motivated and able to work independently while upholding ethical standards.
The salary range is: $64,396-$82,400/annually. Salary ranges will vary and are based on several factors, including geographic location, market competitiveness and equity amongst internal employees in similar roles. Positions may also qualify for SRI's Pay for Outstanding Performance program or the annual Performance Based Compensation program. SRI also has a competitive benefits package, to view details please go to . SRI will accept applications until the position is filled. SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For more than 75 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace.
Job Tags
Permanent employment, Full time, Part time, Work at office, Shift work, Night shift, Afternoon shift,