Clinical Research Coordinator

We are seeking a detail-oriented and dedicated Clinical Research Coordinator (CRC) to manage and execute clinical trials at the site level. The CRC is responsible for coordinating all aspects of assigned research protocols, ensuring compliance with the study protocol, ICH Good Clinical Practice (GCP) guidelines, and all applicable regulatory requirements. This role serves as the primary liaison between the Principal Investigator (PI), the study participants, the Sponsor/CRO, and the Institutional Review Board (IRB).

Key Responsibilities

I. Subject Recruitment and Care • Screening and Enrollment

• Implement patient recruitment strategies, screen potential participants for eligibility against protocol criteria, and obtain Informed Consent in compliance with regulatory and ethical standards.
• Study
• Visits: Coordinate and conduct all required study visits and procedures (e.g., vital signs, ECGs, phlebotomy, physical assessments) according to the protocol schedule.
• Safety
• Monitoring: Monitor subjects for Adverse Events (AEs) and Serious Adverse Events (SAEs). Report all events promptly to the PI, Sponsor, and IRB as required by protocol and regulatory guidelines.
• Participant
• Retention: Maintain regular contact with study participants to promote adherence to the protocol and ensure high retention rates.

II. Data and Documentation Management • Source Documentation

• Develop and maintain accurate, detailed, and concurrent source documents for all study-related activities, ensuring data integrity and traceability.
• Data
• Entry: Accurately and timely enter clinical data into the Electronic Data Capture (EDC) system or case report forms (CRFs).
• Query
• Resolution: Respond promptly and effectively to data queries generated by the Sponsor/CRO, ensuring resolution within specified timelines.
• Record
• Keeping: Manage and maintain the Investigator Site File/Regulatory Binder, ensuring all essential regulatory documents are current, complete, and filed correctly.

III. Regulatory and Operational Compliance • Regulatory Submissions

• Prepare and submit necessary documents and reports to the IRB (e.g., protocol amendments, continuing reviews, safety reports) under the direction of the PI.