Clinical Research Coordinator

Unblinded Clinical Research Coordinator

The Unblinded Clinical Research Coordinator supports the daily operations of assigned clinical trials. It is the responsibility of the Unblinded CRC to communicate with CRC II or CRC III, the Site Manager, and study participants regarding necessary study information. Adherence to site SOPs is required.

When working in an unblinded capacity, the Unblinded CRC’s primary role is managing the Investigational Product (IP) for clinical research trials. This includes, but is not limited to, the receipt, storage, dispensing, destruction, return, and administration of IP. The Unblinded CRC is responsible for maintaining the blind of the study for trials requiring both blinded and unblinded staff roles. The Unblinded CRC must be the expert on all aspects of IP management for each assigned study and will quickly problem-solve issues that may arise with IP management, including reporting dosing discrepancies, ordering issues, and storage excursions.

Reports To: Site Manager / Director

Job Description

CRC Duties

• Inform patients or caregivers about study procedures and expected outcomes
• Monitor study activities to ensure compliance with protocols and all relevant local, federal, state, regulatory, and institutional policies
• Ensure all source documentation is completed while the patient visit is occurring and while the patient is on site for optimal accuracy of data collection
• Complete all source documentation and enter into EDC within 48 hours of patient visit
• Inventory lab and study supplies; notify manager when supplies need to be ordered
• Maintain required records of study activity, including case report forms and drug dispensation records
• Perform specific protocol procedures such as interviewing subjects, taking vital signs, performing electrocardiograms, and collecting laboratory specimens
• Record adverse event and side effect data and confer with investigators regarding reporting of events to sponsors
• Resolve all auto queries in the EDC within 24 hours of query issuance by sponsor
• Dispense medical devices or drugs; calculate dosages, assess drug compliance, and provide instructions as necessary
• Maintain drug accountability, including logging new medication shipments, reporting receipt to sponsor, documenting lost or damaged shipments, and logging dispensed medication to subjects in the appropriate medication log
• Initiate and maintain accurate master logs for each study (ICF, patient ID, and enrollment)
• Participate in quality assurance audits
• Label and organize drug storage space; ensure all received drug is placed in drug cabinets immediately after being checked in and logged
• Maintain accurate daily temperature logs as needed
• Perform other duties as assigned

Unblinded Duties

Prepares the Site for Conduct of the Study

• May include coordination of clinical research trial(s) that do not have a blind component, as required
• Attend Investigator Meetings and Site Initiation Visits
• Train backup Unblinded/Pharmacy Team members as needed
• Obtain all IP training and provide information for others to obtain training as needed
• Ensure the site has obtained all required IP documents and equipment to conduct the study
• Communicate with the sponsor in a timely manner regarding all aspects of IP management
• Prepare source documents for IP preparation and administration, if necessary

Manages All Aspects of Investigational Product

• Inventory investigational product upon receipt
• Maintain unblinded pharmacy binder and all essential documents required in binder
• Maintain accurate IP accountability, including upkeep of any IP logs required by sponsors
• Dispense and prepare investigational products per IP manual
• Administer IP per the IP manual
• Communicate with unblinded monitor and perform unblinded monitor visits
• Ensure temperatures are within range for all IP storage equipment

Required Skills / Abilities

• 6 months – 2 years of clinical research experience preferred
• Ability to work independently and as a member of a team
• GED or High School Diploma required (Some College preferred)