Lead Site Clinical Research Coordinator
Core
Founding Lead Site Clinical Research Coordinator establishing research operations and managing day-to-day conduct of clinical trials (e.g., ATLAS study) at a brain health clinic.
Role type
Lead Site Clinical Research Coordinator (founding)
Builds
Clinical trial operations and site activation for sponsored trials
Domain
Clinical research / Brain health
Deliverable
client delivery
Required skills
IRB and sponsor regulatory submissions, FDA regulations (21 CFR), GCP guidelines, phlebotomy, data entry in EDC systems, study file management, participant screening and enrollment, adverse event reporting
Preferred skills
CCRC or CCRP certification, current phlebotomy certification, Phase I–III trial experience, multi-site coordination, EDC platform familiarity (REDCap, Medidata Rave)
Technologies
REDCap, Medidata Rave
Responsibilities
Coordinate operational aspects of clinical trials from startup through closeout; Stand up research operations at the Fremont clinic; Serve as primary contact to research vendors; Complete sponsor feasibility questionnaires; Assist in development and review of study protocols and informed consent documents; Maintain study files and regulatory binders per ICH/GCP; Prepare and submit IRB applications and adverse event reports; Screen, enroll, and schedule study participants; Obtain informed consent; Conduct study visits and collect data (vital signs, ECGs, phlebotomy); Enter and verify data in EDC systems; Respond to data queries; Abstract and review medical records; Support regulatory submissions across multiple sites; Maintain Delegation of Authority logs; Plan and host sponsor monitoring visits; Mentor junior research staff
Seniority
Senior, hands-on IC with potential for team leadership