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.

Job Tags

Work at office,

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