Clinical Research Coordinator
Company: Renstar Medical Research
Location: Ocala
Posted on: April 1, 2026
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Job Description:
Full-time Description Conduct all aspects of clinical research
in compliance with Renstar SOPs, GCP, ICH, and FDA regulations.
Prepare, submit, and maintain regulatory documents, including IRB
submissions, protocol amendments, parental permission/assent
documents, and other required regulatory filings. Serve as the
primary liaison between Renstar and sponsors, CROs, monitors, and
the IRB. Recruit, screen, and enroll participants into clinical
studies, ensuring eligibility criteria are met. Obtain informed
consent/assent from study participants or their legal guardians,
providing clear and appropriate education regarding study details.
Schedule and conduct study visits according to protocol timelines
and visit windows. Collect, record, and maintain high-quality study
data in source documents and Case Report Forms (CRFs). Maintain and
update study databases and complete data entry in a timely and
accurate manner. Prepare clinical specimens and ensure proper
packaging and shipment to central laboratories, as required by
study protocols. Monitor participant adherence to study procedures
and follow-up requirements; develop strategies to support
compliance. Identify, document, and assist in the reporting and
follow-up of Serious Adverse Events (SAEs). Maintain study drug
accountability records, including inventory, reconciliation, and
secure storage of investigational product. Support monitoring
visits, audits, and regulatory inspections by preparing required
documentation and responding to sponsor queries. Assist in training
internal staff, including nurses and ancillary team members, on
study-specific procedures. Requirements Associate's or Bachelor’s
degree in nursing, Health Sciences, or a related field required.
Certification as a Clinical Research Coordinator (CCRC) preferred
or willingness to obtain. Minimum of 2 years of experience in
clinical research coordination or a related healthcare role. Strong
understanding of clinical trial protocols, GCP, IRB processes, and
regulatory guidelines. Excellent organizational, communication, and
interpersonal skills. Proficient in Microsoft Office Suite and
electronic data capture systems. Ability to manage multiple
priorities and work independently under minimal supervision. Salary
Description $20-$35 per hour
Keywords: Renstar Medical Research, Ocala , Clinical Research Coordinator, Science, Research & Development , Ocala, Florida