- DEPARTMENT: 17070 - Pharmacy DT
- LOCATION: 350 7th Street North, Naples, FL, 34102
- WORK TYPE: Full Time
- WORK SCHEDULE: Variable
JOB SUMMARYThe Investigational Drug Pharmacy Specialist (IDS Pharmacist) is responsible for supporting the safe, compliant, and effective management of investigational medications and research related pharmacy services across the health-system while also providing operational pharmacy services as needed. This position serves as the lead pharmacist for clinical research involving medications and provides oversight of investigational product storage, accountability, preparation, dispensing, return, and documentation.
The role maintains reliable competency and compliance records; supports environmental and equipment documentation; reinforces standardized work; and promptly escalates overdue, failed, missing, or out-of-range items. The IDS pharmacist works under the Director of Pharmacy's supervision and in close partnership with the System Director of Pharmacy, Manager of Clinical Pharmacy Services, Principal Investigators, and the NCH clinical research team, and study sponsors.
This position will based at the NCH Downtown Baker hospital campus, working Monday through Friday.
ESSENTIAL DUTIES AND RESPONSIBILITIES- Other duties may be assigned.
• Investigational Drug Services and Study Management. The Pharmacist must be capable of interpreting complex clinical research protocols and translating protocol requirements into reliable pharmacy workflows.
• Investigational Drug product accountability and inventory control.
• Reviews proposed clinical trials protocols to evaluate pharmacy operational requirements, medication safety considerations, preparation complexity, blinding requirements, and overall pharmacy feasibility.
• Train clinical staff pharmacists on research protocols if necessary by developing education regarding new research protocols and investigational medications.
• Develop study-specific pharmacy workflows, dispensing procedures, drug preparation instructions, and other required operational documents.
• Maintains appropriate documentation of dose preparation, dispensing, administration-related information, and waste.
• Ensures investigational medications are used only in accordance with authorized research protocols, applicable institutional approvals, and study requirements.
• Participates in the NCH Investigational Review Board.
• Serves as pharmacy representative during sponsor monitoring visits, study audits, regulatory inspections, accreditation surveys, and other research related reviews.
• Promotes standardization, reliability, and continuous process improvement throughout research pharmacy operations.
• Maintains professional knowledge regarding clinical research regulations, investigational drug management, medication safety, sterile compounding, and hazardous drug handling.
EDUCATION, EXPERIENCE AND QUALIFICATIONS• High School Diploma or GED required.
• State of Florida Pharmacist License required.
• Greater than 1 year of health-system hospital pharmacy experience.
• Reliability, integrity, and exceptional attention to details.
PREFERRED EXPERIENCE: • Experience supporting USP/ compliance, environmental monitoring, competency testing, audits, and accreditation surveys.
• Completion of PGY1 pharmacy residency.
• Previous experience managing investigational medications or participating in clinical research preferred.
• Experience and knowledge of oncology pharmacy.
