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SRI · 1 day ago

Clinical Research Coordinator III

US-MI-Plymouth

Full-time

Hybrid

Mid, Senior Level

$64K/yr - $82K/yr

4+ years exp

SRI is an independent nonprofit research institute dedicated to innovative solutions in biosciences, and they are seeking a Clinical Research Coordinator III to manage complex clinical research studies. The role involves participant recruitment, data management, and ensuring compliance with regulatory requirements while mentoring junior staff.

Advanced MaterialsArtificial Intelligence (AI)Computer VisionCyber SecurityNon ProfitRobotics

No H1B

U.S. Citizen Only

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

Qualification

Clinical trial experienceICH-GCP knowledgeBiospecimen handlingBLS certificationACLS certificationEDC systems proficiencyRegulatory submission experienceLeadership abilityOrganizational skillsProblem-solving skillsCommunication skillsInterpersonal skills