Clinical Research Coordinator

Job Description

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.

• 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.