The incumbent is to provide support to the pharmacist of a phase III randomized controlled trial. They will assist with management of the trial pharmacy, in accordance with Drug Regulatory Authority of Pakistan (DRAP), Good Clinical Practice (GCP), and Good Pharmacy Practice (GPP) guidelines.
Pharmacy regulatory compliance
· Ensure that all study drugs are stored according to protocol/SOP/manufacturers instructions in restricted access area to prevent loss or use by unauthorised individuals.
· Maintain IP storage area visit log.
· Maintain pharmacy temperature conditions and continuous temperature monitoring: record the storage temperature and relative humidity twice daily, except for the days off.
· Report any deviation to the Pharmacist.
· Perform weekly uploads from the data logger records to an electronic device and USB key, and retain the printed version of data logger reports in the pharmacy site file.
· Assist with pharmacy quality assurance and quality control processes.
· Complete and maintain pharmacy records for the sponsor and regulatory audits.
· Assist monitors in drug accountability activities.
· Investigational product (IP)
· Assist with procurement of trial medication.
· Receive trial drugs from suppliers; document receipt and resolve discrepancies.
· Maintain accurate and proper records for all drugs received and distributed by the trial pharmacy, according to trial SOPs.
· Prepare weekly medication blister packs for participants as per prescriptions from trial doctors, in accordance with trial SOP, under direct supervision of the trial pharmacist.
· Label trial medication before dispensing, in accordance with trial SOP, under supervision of the trial pharmacist.
· Dispense trial medication, as per specific protocol/SOP requirements, under the supervision of the trial pharmacist.
· Assist the treatment coordinator in counselling and educating patients on drug administration, side effect, and adherence under direct supervision of the trial pharmacist.
· Receive and reconcile IP returns.
· Assist with pill counts and adherence monitoring.
· Return and/or properly dispose of trial drugs as per protocol/SOP.
· Maintain stock control and a record of dispensed medication, according to trial SOPs.
· Maintain IP accountability records.
· Maintain prescription records against which IP is dispensed.
· Maintain pharmacy sections of the Site Master File.
· Communicate with trial medical officers, nurses, treatment coordinator and sponsors when needed. Attend regular meetings with the endTB trial team.