Unblinded Clinical Research Coordinator (CRC)

Job Description : Unblinded Clinical Research Coordinator

need IP, investigational drug experience if no clinical research experience prior

The Unblinded Clinical Research Coordinator (CRC) is responsible for supporting the daily operations of assigned clinical trials and ensuring all study procedures are performed according to protocol, regulatory requirements, and site standard operating procedures (SOPs).

In this unblinded capacity, the CRC's primary role is to manage the Investigational Product (IP) throughout the study lifecycle, including receipt, storage, dispensing, administration, return, and destruction. The Unblinded CRC also ensures that study blinding is maintained for trials requiring separation of blinded and unblinded staff roles and serves as the subject matter expert for IP handling and documentation.

Reports To :

Site Manager or Director

Core Responsibilities

Clinical Research Coordination

• Educate study participants or caregivers on study procedures, expectations, and potential outcomes.
• Monitor study activities to ensure compliance with protocols, regulations, and institutional policies.
• Complete and maintain accurate source documentation during and immediately following patient visits to ensure data integrity.
• Enter source data into the Electronic Data Capture (EDC) system within 48 hours of each visit.
• Track and manage study and laboratory supplies; notify management when reordering is needed.
• Maintain comprehensive study records, including case report forms and drug dispensation logs.
• Perform assigned protocol procedures such as vital signs, ECGs, specimen collection, and subject interviews.
• Document adverse events and side effects, communicating relevant findings to investigators for sponsor reporting.
• Resolve EDC queries within 24 hours of notification.
• Dispense and account for investigational drugs or devices per protocol, including dosage calculations, compliance checks, and patient instructions.
• Maintain accurate master logs for informed consent, patient IDs, and enrollment.
• Participate in site audits and quality assurance activities as needed.
• Label, organize, and store all investigational products properly, maintaining accurate daily temperature logs.
• Perform other study-related tasks as delegated by the investigator or site leadership.

Unblinded Study Responsibilities

Investigational Product (IP) Management

Required Skills & Abilities

Education & Experience