Looking for a strong Clinical Research Coordinator with injection experience to join our team!
Overview
Unblinded Responsibilities
Site Preparation
Prepare the site for study initiation and ensure all requirements for study conduct are met.
Coordinate clinical research trials that do not include a blinded component, as applicable.
Attend Investigator Meetings and Site Initiation Visits (SIVs).
Train backup Unblinded/Pharmacy Team members as needed.
Complete all required training related to the Investigational Product (IP) and assist others in obtaining necessary IP training.
Confirm that the site has received all required IP-related documentation and equipment before study initiation.
Maintain timely and accurate communication with the sponsor regarding all aspects of IP management.
Prepare source documentation for IP preparation and administration, if applicable.
Investigational Product (IP) Management
Inventory and verify all investigational product shipments upon receipt.
Maintain the unblinded pharmacy binder and ensure all essential IP-related documents are up to date.
Ensure accurate IP accountability and maintain all IP logs as required by the sponsor.
Prepare and dispense investigational products according to the IP manual.
Administer IP in accordance with the IP manual and study protocol.
Coordinate and communicate with the unblinded monitor; participate in unblinded monitoring visits as required.
Ensure that all IP storage equipment maintains temperatures within the required range and that logs are reviewed regularly.
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