Clinical Research Coordinator III

SRI International•Plymouth, MI

14h•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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).
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.

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.