Job Description

Job Summary:

The Clinical Research Coordinator (CRC) is responsible for managing and coordinating clinical research studies in compliance with regulatory, institutional, and sponsor guidelines. The CRC ensures the integrity of study data and the safety and rights of study participants.

Key Responsibilities:

• Coordinate day-to-day activities of assigned clinical trials.
• Recruit, screen, and enroll study participants according to protocol inclusion/exclusion criteria.
• Obtain informed consent and ensure ongoing participant compliance.
• Schedule and conduct study visits and procedures.
• Collect, document, and maintain accurate study data in case report forms (CRFs) and electronic databases.
• Monitor participant safety and report adverse events per protocol and regulations.
• Communicate with sponsors, monitors, and regulatory bodies.
• Prepare and submit IRB documentation, amendments, and continuing reviews.
• Ensure proper handling, storage, and accountability of study drugs/devices if applicable.
• Maintain regulatory binders and study documentation in audit-ready condition.
• Train and supervise research assistants or junior staff, if applicable.

Qualifications:

• Bachelor's degree in a health-related field or equivalent experience.
• 1–3 years of clinical research experience preferred.
• Knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB processes.
• Certification (e.g., ACRP or SOCRA) preferred but not required.
• Strong organizational, communication, and problem-solving skills.
• Proficiency with electronic data capture systems and Microsoft Office.

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