Job Description

The Unblinded Clinical Research Coordinator (CRC) is responsible for coordinating all unblinded aspects of clinical trials, including investigational product (IP) management, drug accountability, and subject randomization. This role requires strict adherence to protocol while maintaining confidentiality to protect the integrity of the study.

Key Responsibilities:

• Manage and document investigational product (IP) dispensing, preparation, and return/destruction according to protocol
• Maintain accurate and complete drug accountability records
• Handle randomization procedures and unblinded subject assignments
• Collaborate closely with pharmacy, sponsor, and blinded research staff
• Monitor subjects for compliance with IP administration and report deviations
• Support monitoring visits and audits focused on unblinded study components
• Ensure regulatory compliance with GCP, ICH, and FDA guidelines

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