Reports to Head Pharmaceutical Services, Investigators of Record. The incumbent is responsible for all pharmaceutical issues within the Clinical Research Sites.
Main duties
- Establishes all necessary forms, policies and procedures to ensure the safe and proper use of all study products including the preparation of a Pharmacy Plan and Standard Operating Procedures for Drug Storage; Temperature Monitoring: Drug Access Protocol; Dispensing Protocol.
- Adheres to Pharmaceutical Affairs Branch (PAB) Pharmacy Guidelines and Instructions for Division of AIDS (DAIDS) Clinical Trials Networks as well as institutional, local, regional, and country regulations.
- Maintains the confidentiality of the participant, the participant’s pharmacy file, and the study product accountability record as well as maintain the blinding of the participant’s treatment assignment to investigators, study nurses, clinic staff and the participant.
- Ensures that study products are dispensed only to eligible study participants and that participants have signed an informed consent before dispensing protocol-provided study products.
- Ensures that study products are dispensed only after the written order of the Investigator of Record or upon the order of a licensed clinician directly responsible to the IoR
- Maintains accurate records of receipt, control, dispensing and accountability of protocol provided study products and other drugs specific to the study. Including dates, quantities, lot numbers, use by participants, and amounts s returned or disposed of at the request of the Sponsor
- Ensures adequate space, equipment, and supplies for the storage, preparation, packaging, and dispensing of study products including products that require special handling.
- Ensures proper verification on the accountability records whenever protocol-provided study product supplies are returned, that all remaining supplies including returns from participants have been returned either to the Sponsor other source.
Qualifications
- Degree in Pharmacy
- Experience with management of drugs and related commodities
- Knowledge of the MOH Healthcare system
- Computer literate
- Work with minimum supervision
- 3 years minimum years’ experience
- Valid practicing license
