At the direction of the Investigational Drug Services Pharmacist Supervisor, responsibilities include:
* Maintain drug accountability records of receipt, dispense, and disposition of investigational products according to all applicable requirements.
* Maintain investigational product information records regarding the preparation, stability, compatibility and precautions assigned.
* Order, or coordinate the ordering and return of investigational products as appropriate.
* Adhere to both hospital and protocol policies and procedures to prepare injectable and oral investigational products and chemotherapy as appropriate.
* Follow requirements by the protocol sponsor and the FDA to return or provide for the destruction of unused investigational products.
* Coordinate and schedule meetings between sponsor representatives, monitors, study teams and the Pharmacy for pre-site or initiation visits or closing of studies.
* Package and distribute investigational products and materials to patients or other satellite hospitals involved in investigational studies, according to the limits of accepted standards.
* Assists with the preparation of internal and external audits as needed.
* Maintain supply area for returned used and unused investigational product until the sponsor monitors verify and dispose of them appropriately.
* Perform a complete inventory of all investigational products quarterly and document the results. Work with the appropriate parties to resolve discrepancies as quickly as possible.
* Store investigational products in required storage temperatures and regularly monitor temperature records. Report temperature excursions as required by sponsors.
Write and review study-specific dispensing guidelines.
Key Responsibilities:
1. Answers Phones. 2. Prepares prescription and non-prescription medication and/or devices. 3. Stocks and replenishes stock locations and automated dispensing machines and/or robots. 4. Serves as a preceptor and assists with orienting and training of pharmacy department staff. Provides CII oversight. 5. Communicates supply issues, problems or discrepancies to the appropriate personnel. 6. Assists with workflow management Inpatient and Infusion Only: 7. Prepares intravenous admixtures or other sterile drug products (including antineoplastic, investigational and hazardous medications) in accordance with USP chapters and under supervision of a licensed Pharmacist. 8. Prepares or compounds non-sterile drug products (including antineoplastic, investigational and hazardous medications) in accordance with USP chapters and under supervision of a licensed Pharmacist. 9. Utilizes closed system transfer devices to limit potential exposure of the environment to hazardous medications. 10. Follows investigational protocols in the preparation of study medications, maintains records of preparation, stability, and dispenses as required. 11. Maintains the hardware and software of the department's multiple computer systems.
12. Must be willing to travel to System Pharmacy sites within NH & VT.
13. Performs other duties as required or assigned.
Minimum Qualifications: • Associates degree in a health or related field, with 1 year of pharmacy experience, or the equivalent in education and experience preferred. • Ability to work in a fast paced environment with accuracy. • Ability to multitask and attention to detail. • Ability to maintain composure under stressful situations.
Required Licensure/Certification Skills: •Registered Pharmacy Technician with the NH Board of Pharmacy required. •Certified Pharmacy Technician (CPhT) certification required. •BLS Certification required within 30 days of hire for Pharmacy Technicians in the Retail or Specialty Pharmacy