Prepares, compounds, manufactures and dispenses medications, biologic agents, natural products, medical devices and related materials for ongoing research trials.
Manages recordkeeping, shipping, ordering, receiving, storage, retention/destruction and related inventory activities in compliance with good clinical practices and the requirements of individual study sponsors.
Participates in study initiations, monitoring and closeout visits, quality assurance audits and other related meetings with study sponsors and their representatives, regulatory agencies and others.
Ensures the accuracy and integrity of products prior to their dispensing to study participants.
Maintains compliance with all applicable Penn and UPHS policies, sponsor guidelines and state and federal laws and regulations.
Reads, interprets and processes prescriptions for investigational medications; clarifies orders with prescribers as needed.
Accurately dispenses medications and prepares sterile products following proper aseptic technique.
Serves as a resource to other members of the research community as well as to UPHS pharmacists and nurses; provides drug information for investigational agents as needed; assists investigators in the development of investigator-initiated trials, formulation of medications and preparation of IND applications.
Prepares clearly written staff procedures for new trials, which accurately reflect the protocol regimen and sponsors specific requirements; updates procedures to correspond to protocol revisions.
Oversees the work performed by clinical research technicians, pharmacy interns, pharmacy residents and clerkship students to ensure that performance standards are maintained and that work is accurate in accordance with applicable state and federal regulations and Penn and UPHS policies.
Participates in rotating on-call coverage for situations that require assistance after hours.
Performs related duties as required and assigned by manager.
9.Machines/Tools & Equipment:
Computers and software (including database and web-based applications used by the IDS in the day-to-day management of clinical trials)
Office machines: copiers, fax machines, printers, telephones, etc
Sterile: glove box isolators and other equipment/supplies needed to prepare sterile products.
Non-sterile: manual and automated tablet counters, heat sealing devices, heat presses and other related equipment
Manufacturing: blenders or mixers, capsule filling equipment
Laboratory: basic laboratory equipment and testing equipment (including equipment used to identify or confirm the suitability of medications or ingredients)
University Of Pennsylvania Health System