Pharmacy Supervisor (2886)

Pharmacy Supervisor will be responsible for quality oversight to unblinded team members, responsible for training
of unblinded staff members, and dispensing and administering Investigational Products (IP) as part of clinical
research trials.

DUTIES & RESPONSIBILITIES

• Provide IP management oversight to assigned sites
• Supervise and maintain records of all medications and supplies.
• Ensure compliance with study-specific blinding plans.
• Provide consultative support regarding the preparation and dosing of drugs.
• Maintain documentation of IP accountability and necessary related supplies: receipt, dispensing, return to sponsor/destruction.
• Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare, dispense, and administer IP for clinical trials.
• Understand and apply all applicable site procedures.
• Ensure receipt and proper storage of IP and related supplies.
• Review most recent pharmacy manuals and protocols in order to provide input on source documentation, clinical and pharmacy supply needs.
• Be prepared for and available at any required meetings with DM staff, sponsors, monitors, auditors, and regulatory authorities to review IP accountability and other study-specific information.
• Oversight and QC of site temperature monitoring and reporting.
• Any other duties/tasks assigned by the manager
• Ensure sites adherence to aseptic technique guidelines during preparation and administration of IP
• Inventory management of IP and related supplies, ensuring adequate on hand supplies and quarantine of expired products.
• Complete DMCR required training, including GCP and IATA.
• Maintain a working knowledge of current FDA regulations, CGP/ICH guidelines, organizational SOPs guidance documents and study protocols.
• Completing Sponsor-required training prior to study start, to include, but not limited to:
  • Sponsor provided and IRB approved protocol
  • All amendments
  • Investigator brochure
  • Sponsor specified EDC and/or IVRS
  • Pharmacy manual
•  This includes completing the above mentioned training prior to any study related procedures being conducted on that said protocol should the uCRC be added to a protocol post-study start up.
• Complete applicable source documentation following ALCOA guidelines
• Maintain assigned Pharmacy Site Files per sponsor requirement including, but not limited to:
  • Sponsor provided and IRB approved protocol and amendments
  • Investigator brochure
  • Pharmacy manual
  • Sponsor and DMCR required training documentation
  • Preparation and administration source documentation
  • IP accountability logs
  • Correspondence
• Schedule and conduct unblinded SIVs, uIMV, and uCOV
• Ensure timely and adequate follow up and resolution to IP related queries and deviations
• Provide quality control review of all IP preparation, dosing and administration, IP and supply accountability and inventory,
• Completion of QAR Reports
• Submit daily/weekly reports to Regional Pharmacist regarding the site status
• Create and conduct protocol and site procedure unblinded trainings
• Ensure site readiness for new/incoming studies
• Compound, dispense and administer prescribed IP as needed by Sponsor approved protocol

KNOWLEDGE & EXPERIENCE

Education:

• Bachelor's Degree or equivalent education and experience combination required

Experience:

• 1 year(s) unblinded CRC III Experience

Credentials:

• LPN/LVN (Licensed Professional/Vocational Nurse), RN or CMA (Certified Medical Assistant) a plus
• Licensure which fulfills State requirements to complete tasks, i.e., administration of vaccinations
• Pharmacy Technician Certification a plus

Knowledge and Skills:

• Computer proficiency, especially Word, Excel, Outlook, and Google Docs.
• Ability to use computer applications for data capture and for general communications
• Communicate effectively both orally and in writing.
• Able to create source documentation based on protocols/pharmacy manuals
• Able to manage small to medium sized team
• Outgoing personality Well-organized with extreme attention to detail.
• Must be able to multitask.
• Bilingual (Spanish) preferred but not required