Job Detail

Job Position - Department

Pharmacist - EndTB Clinical Trial (Kotri) - EndTB Clinical Trial

Experience

1-2 year(s) of relevant experience

Education

Pharm - D from a recognized university

Last Date

11/30/2021 12:00:00 AM

Job Description

  • To provide general support to the endTB Trial Coordinator for initial clinical trial(s) submission to Drug Regulatory Authority (DRAP).
  • To be familiar with ICH GCP, appropriate regulations, and endTB clinical trial(s) SOP’s and protocol.
  • To organize and supervise the study drug management according to protocol/SOP/pharmacy manual/manufacturer’s instructions with the support of the junior pharmacist:
  • All study drugs are stored according to protocol/SOP/manufacturer’s instructions in restricted access area to prevent loss or use by unauthorised individuals.
  • Pharmacy temperature conditions and continuous temperature monitoring is maintained, data recorded and archived in pharmacy site file.
  • Perform weekly upload from data logger records to an electronic device and USB key and retain the printed version of record in pharmacy site file.
  • Report any deviations to the Clinical trial Pharmacist.
  • Pharmacy quality assurance and quality control processes are in place
  • Pharmacy records are completed and maintained for the sponsor and regulatory audits
  • Assistance is given to internal monitor(s) in drug accountability visits.
  • To ensure proper management of study drugs documentation (e.g. ISF, CIF, etc.).
  • Assist monitors in drug accountability activities.