Works closely with the ACPRU Investigational Pharmacist
Maintain accurate drug accountability: Ensures IP-related clinical trial records including the receipt, preparation, retention samples, dispensing and return of IP are maintained per USP, DEA and GCP requirements. Ensure compliance to randomization schedule for blinded studies, responsible for verification of study set up. Ensure all pharmacy materials are available and of the appropriate quality and quantity throughout the execution of every study.
Maintain accurate inventory of pharmacy supplies and ancillary supplies (e.g. rental pumps, infusion sets, IV fluids)
Assist with supporting quality audits and regulatory inspections conducted at ACPRU
Reviews SOPs, Work Instructions and Business Process documents pertaining to ACPRU pharmacy operations, including procedures concerning quality assurance, security of controlled substances, and disposal of hazardous waste and drugs
Review protocols and provide input on study-specific materials and activities that impact ACPRU workflow.
Review Dose Preparation Instructions and associated study records/templates. Including collaboration with Pharma Science and Device Development throughout all phases (0 to 4) of development at global sites.
Ensure compliance with federal and state laws, regulations, and policies governing pharmacy operations
Effectively communicates with ACPRU staff, AbbVie Management, and external vendors