Posted in: Executive Management in United States | Posted: |
The Clinical Pharmacy Manager manages the preparation, compounding, manufacturing, and dispensation of investigational drugs and materials issued by the department of oncology for ongoing research addition, the clinical pharmacy manger will be responsible formanaging required record-keeping, shipping, ordering, and inventory activities;ensuring the accuracy and integrity of products prior to their delivery to trial subjects; ensuring compliance with all applicable medical center, governmental, and sponsor regulations, laws and policies related to the conduct of clinical trials involving investigational or marketed drugs; developing IDS policies as required; serving as a representative of the protocol review committee to assist in protocol review and approval; maintaining records to meet sponsor requirements, FDA regulations and legal requirements for pharmacy operations. The clinical pharmacy manager reads, interprets and processes orders for investigational drugs; communicates and collaborates with the EPIC beacon team to build treatment/therapy plans as needed; Accurately dispenses medications and prepares sterile products, following proper aseptic and cytotoxic technique;Serves as a resource to the clinical trials department, healthcare professionals and investigators in the development of investigator-initiated studies;Oversees the work performed by other pharmacy personnel involved with the investigational drug service to ensure that performance standards are maintained, and that work is accurate and in accordance with state, federal and organizational regulations. Performs other related responsibilities as required.
REQUIREMENTS
Bachelor's Degree in Pharmacy required, PharmD preferred
Active NYS Pharmacy License
Current Pharmacy registration CITI certification (GCP, Human Research, Biomedical Research)
3 to 5 years of IDS Experience
Completion of an ASHP accredited PGY 1 or PGY 2 pharmacy Residency Research rules and regulations, protocol-specific training required.
This position requires knowledge of clinical information systems (EPIC), nCOUP protocol set-up/configuration; catalog building; receipt and destruction, dispensing systems, automated sterile product systems, FAX machines, Capsule preparation machines. Digital Balances/ Torsion balances and Digital Thermometers Microsoft Word, Excel, PowerPoint, One Drive