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Posted 10mo ago

Clinical Research Coordinator

@ Renstar Medical Research
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Ocala, Florida, United States
OnsiteFull Time
Responsibilities:Coordinate studies, Enroll participants, Maintain data
Requirements Summary:2+ years in clinical research or related healthcare role; nursing/health sciences background; GCP/IRB knowledge; proficient in MS Office and EDC; strong organizational and communication skills.
Technical Tools Mentioned:Microsoft Office, Electronic Data Capture (EDC) systems
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Job Description

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.