Pharmacy Manager

Job Summary

The IDS Pharmacy Manager must be knowledgeable in standard pharmacy practices, including USP<797> and USP<800>, in addition to research and oncology care practices. The IDS Pharmacy Manager advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care. The IDS Pharmacy Manager is responsible for evaluating, hiring, and training new staff.

Essential Duties and Responsibilities

Essential and other important responsibilities and duties may include but are not limited to the following:

Protocol Compliance

• Reviews potential future protocols for feasibility and attends weekly protocol review meetings.
• Attends site initiation visits.
• Participates in quality control checks for study-specific forms, both for new studies and for protocol updates.
• Creates IDS specific training documents for staff for new protocols using the IDS template.
• Reviews all investigational protocols, amendments, and clarification letters. Updates concomitant medication screening note, medication diary / diaries and / or other study-specific forms, Varian Regimens, and Vestigo (electronic drug accountability program) as required.
• Creates IDS specific training documents for staff as required for protocol updates / IP manual updates, etc.
• Participates in providing timely, informative, and accurate communication with the interdisciplinary team to ensure protocol compliance and timeliness of protocol-related procedures.
• Performs concomitant medication screens on all patient who are undergoing screening for clinical trial enrollment. Answers concomitant medication questions for research staff and patients though out trial enrollment.
• Ensures evidence-based symptom management is provided to patients as permitted by the protocol.

Medication Dispensing and Preparation for Conventional and Investigational Products (IP)

• Reviews all orders for accuracy of dose and dose calculations.
• Reviews patient-specific factors to determine eligibility for treatment, including, but not limited to laboratory values, required protocol assessments (ECHO / MUGA, disease assessments, ophthalmology exam, pulmonary function, etc.), consent / reconsent and toxicity resolution.
• Develops compounding tools for all IV investigational agents and trains technicians on mixing process for all IP and conventional agents, if required.
• Checks all IV and PO doses prepared by the IDS Pharmacy technician.
• Have an excellent working knowledge of good clinical practice (GCP), good manufacturing practice (GMP) and all procedures, legislation or national guidelines relating to aseptic preparation (USP<797>) and dispensing of hazardous medication (USP<800>) and clinical trials.
• Assist in the provision of a high-quality investigational drug service, including provision of pharmaceutical care.
• Ensure that IDS services are flexible and responsive to research staff and that the services meet patient requirements / needs.
• Provides drug information to physicians, nurses, and other health care professionals.

Management of Investigational Product and Drug Accountability

• Maintains responsibility for the management of the inventory for protocols, including ordering, receiving, and returning IP, as required.
• Ensure that correct procedures for receipt of IP and storage of IP are followed.
• Maintain appropriate and accurate records for all protocols, including drug accountability, drug receipt, temperature monitoring, expiration / retest dating and staff training, etc.
• Ensure that procedures for the return and disposal of IP are current and being followed.
• For oral IP: review patient medication diaries and IP returns for accuracy and completeness in conjunction with the treatment room nurses and research coordinators. Document this review and return it in Vestigo. Ensure medication diary is scanned and uploaded into eDOCs.
• Monitors IDS activities, daily, to ensure adherence to protocols, standard operating procedures, IDS Workflows and dispensing procedures.
• Ensure that products used in clinical trials are managed according to standard operating procedures (SOPs), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and any other applicable regulations.
• Assist with monitoring visits and answering any monitor queries.

Administrative and Supervisory Responsibilities

• Provides direct supervision and training to IDS pharmacists.
• Provides direct supervision and training to IDS pharmacy technicians for preparation of medications for dispensing, including compounding of IV and hazardous medications and oral IP doses.
• Complies with NEXT Oncology SOPs and Workflows ensures all IDS staff are appropriately trained and in compliance with SOPs.
• Contributes to the development, integration and monitoring of written procedures and workflows covering all aspects of the IDS.
• Oversees monthly conventional inventory, investigates inventory discrepancies / issues, and performs adjustments, as required.

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