Job Description

McKesson's Investigational Products Center (IPC) plays a critical role in the successful execution of clinical trials. The Research Pharmacist in the IPC is responsible for performing rigorous quality control checks on all orders, verifying order accuracy, and resolving issues in collaboration with site staff. Additionally, the role will evaluate protocol-specific requirements and apply professional judgment to design and implement processes for the storage, ordering, and shipping of investigational products. Position will primarily be on-site at the IPC located near the north side of DFW Airport, with occasional work from home. Position works standard business hours Monday through Friday. Key Responsibilities: Leads the discussion on study start-up with sponsors/CROs related to investigational drug for clinical trials utilizing the Investigational Products Center for storage, order processing and shipping of Investigational Products. Evaluates investigational product specific requirements from the protocol, clinical trial sponsor/CRO and utilizes professional judgement and makes decisions on how process need to be defined and setup for the management and proper storage of investigational product including temperature control monitoring and expiry management. Works with sponsor/CRO to define IVRS requirements which coordinate with site investigational product ordering. Coordinates with other team members involved in Study Start Up processes. Utilizing professional judgement, reviews study protocols and sponsors IVRS system and makes decision and determination on how to set up study within the Investigation Products Center. Develops and creates work instructions and information sheets which includes proper product labelling, and any other applicable information to meet protocol specific requirements. Conducts Investigational Products Center study specific training to ensure all personal are appropriately trained. Provides quality control checks on all shipments sent to sites including investigational product or other clinical trial related orders. Prepares and processes Investigational Product Orders. Checks orders for completeness of information. Verifies patient information and proper authorizations and/or certifications. Re-checks orders for accuracy before processing and shipping. Processes and fills orders in an accurate and timely manner, and preparing all orders within S.O.P and department guidelines/processes. Consults with site staff and utilizes professional judgement to resolve complaints and IVRS issues. Reviews study documents and utilizes professional judgement to make determination on impacts to Investigational Products Center processes. Responsible for determining and designing any process changes if required and communication to the team. Responsible for implementing changes, and provides quality checks as required. Leads and/or participates in process improvement teams. Implements process improvements to continue to improve the customer experience, quality, and operational efficiency of the investigational products center. Provides investigational product and investigational product center information by answering questions of site and central operations personnel.

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