Description
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.
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.
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.
- 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.
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.
- Ensures that correct procedures for receipt of IP and storage of IP are followed.
- Maintains appropriate and accurate records for all protocols.
Administrative and Supervisory Responsibilities
- Provides direct supervision and training to IDS pharmacists and pharmacy technicians.
- Complies with NEXT Oncology SOPs and Workflows.
- Contributes to the development, integration and monitoring of written procedures and workflows covering all aspects of the IDS.
Education Responsibilities
- Orients IDS staff, pharmacy residents and pharmacy students to the IDS role with respect to protocols, as required.
- Maintains continuing education requirements to maintain Pharmacy and Preceptor License, any certifications and protocol compliance training.
Data and Document Management and Information Technology
- Assists in the scanning, review and uploading of protocol documentation into eDOCs.
- Uploads resume, license(s), certification(s) and training documents for IDS employees into eDOCs.