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
Prepare the site for study initiation by ensuring all required documentation, supplies, and equipment are available.Attend investigator meetings and site initiation visits as required.Train and support backup unblinded or pharmacy team members.Obtain and maintain training on investigational product procedures and ensure others are appropriately trained.Communicate proactively with sponsors regarding all IP-related issues and documentation.Prepare and maintain source documents for IP preparation and administration.Investigational Product (IP) Management
Conduct inventory of investigational products upon receipt and maintain complete accountability records.Maintain the unblinded pharmacy binder and all associated essential documents.Dispense, prepare, and administer investigational products according to protocol and IP manuals.Conduct and document unblinded monitoring visits as required.Monitor and document all temperature logs for IP storage and report any excursions immediately.Required Skills & Abilities
6 months to 2 years of experience in clinical research preferredStrong understanding of GCP, FDA, and ICH regulationsExcellent organizational skills and attention to detailAbility to work independently and collaboratively in a fast-paced environmentEffective written and verbal communication skillsAbility to travel locally between multi-site locations as neededEducation & Experience
High school diploma or GED required; some college coursework preferredMedical or scientific certification (e.g., CMA, CPhT, LPN, etc.) preferredPrior experience in pharmacy operations, investigational drug management, or clinical research coordination strongly preferred