Clinical Research Coordinator at Renstar Medical Research – Ocala, Florida
Renstar Medical Research
Ocala, Florida, 34470, United States
Posted on
Updated on
Job Function:Medical
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About This Position
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.
- 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.
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Job Location
Ocala, Florida, 34470, United States
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Job Location
This job is located in the Ocala, Florida, 34470, United States region.
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