**__**Description:
Assists the Pharmacy team in the administrative and technical operations of the pharmacy. Assists in the development and continued evaluation of a training process for Clinic staff interacting with the pharmacy, to assure compliance with pharmacy procedures (i.e., drug accountability, storage, administration of doses, and proper documentation of the trail of study drug to and from the pharmacy).
Primary Responsibilities:
Assists staff in receipt, storage, dispensing, and return of drug. Acts as liaison with Pharmacy management, Clinical teams, Clinic Project Managers, and Clinical Operations and Logistic Departments.
Prepares and reviews the accuracy of labels, assists in packaging of doses, and accounts for all dosage units entering and leaving the Clinic per FDA regulations and guidelines and per study protocol requirements. Assures proper protocol and regulatory procedures are followed in the receipt and handling of drug by team members and other staff responsible for dosing.
Assists in assuring that study drug product prepared and/or checked by pharmacy technical staff is of the highest quality standards to ensure the safety of the study participants and integrity of the study.
Assists in the continued evaluation of a training program for Clinic staff that interacts with the pharmacy, to assure compliance with pharmacy procedures.
Assists with the completion of all required in-house sterile technique skills tests for all staff.
Interacts with sponsors/clients in regard to potential and on-going studies. Explains K2 Med procedures and responds to sponsor/client requests regarding handling of drug, close-out issues, etc. Assures close-out of studies are handled properly (i.e. drug is returned to sponsor, stored correctly, etc., depending on protocol/sponsor requirements).
Performs other duties as assigned.
Knowledge, Skills, and Abilities:
Qualifications: