Job Description
JOB SUMMARY:
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.
TASKS & ACCOUNTABILITIES:
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 unauthorized individuals.
- Maintain Investigational Products (IP) storage area visit log.
- Maintain pharmacy temperature conditions and ensure 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 if required.
- Receive trial drugs; 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, dispense & label weekly medication blister packs for participants as per prescriptions from trial doctors, in accordance with trial SOP, under direct supervision of the Site/trial pharmacist along with it’s distribution in absence of dispenser or as per requirement.
- Assist the treatment coordinator in counselling and educating patients on drug administration, side effect, and adherence.
- Receive and reconcile IP returns, with proper documentation.
- Assist with pill counts.
- Maintain stock control and record of dispensed medication, according to trial SOPs.
Record management
- Maintain IP accountability records.
- Maintain prescription records against which IP is dispensed.
- Maintain pharmacy sections of the Investigational Site Files.
Communication
- Communicate with trial medical officers, nurses, treatment coordinator and sponsors when needed.
- Attend regular meetings with the endTB trial team if needed.
JOB SPECIFICATIONS:
Work Experience:
- Category A Registration from Pharmacy council Sindh.
- Previous clinical trial or research experience (advantageous).
- Experience working on MDR-TB patient clinical documents (advantageous).
- Experience managing staff (advantageous).
- Fresh or one year of experience in relevant field.