Description:
Main purpose of the job:To implement pharmaceutical services as per protocols for clinical research studies conducted at Wits RHI research sites Location:
7 Esselen Street, Hillbrow, Wits RHI Research Centre Clinical Research Site (CRS) Key performance areas:
Comply with all relevant legislative and regulatory requirements Implement and maintain study specific procedures according to regulatory requirements and protocol for all relevant studies at site Assist in setup of compliant pharmacy services at trial sites, in person, on calls or via email. Perform periodic oversight of pharmacy services at trial sites and issue reports accordingly Compile and revise study or pharmacy related SOPs Train staff on protocol and study specific SOPs Maintain study documentation Conduct internal and organization-wide monitoring and quality assurance Identify any regulatory issues and bring it to the attention of the Project Manager and Principal Investigator Prepare for any monitoring or auditing visits from regulatory authorities or sponsors Periodic review of all pharmacy SOPs and quality management plan Manage general housekeeping of the Pharmacy and Clean Room according to infection control standards Interpret prescriptions and dispense drugs according to protocol Advise participants on the correct use of or adherence to drugs Maintain drug accountability records for all drugs Conduct stock control to ensure the correct availability of stock levels and expiry of drugs Administer, process and file relevant documentation Order medicines (scheduled, cold chain, investigational and concomitant) from suppliers to ensure sufficient stock Ensure appropriate destruction of all expired and quarantined drugs Maintain appropriate storage conditions Respond to temperature excursions and call outs as necessary Manage importation of study products and related supplies Manage bulk orders and distribute stock to affiliated sites as required Track stock levels at affiliated sites to ensure uninterrupted implementation of the trial Oversight of study product management at affiliated sites Setup and compile required files and SOPs for new studies Compile periodic drug accountability reports and study specific reports as and when required Complete Pharmacy CRFs and file accordingly Maintain and file all relevant pharmacy specific participant documentation Comply with Good Clinical Practice (GCP), Protocol requirements and Standard Operating Procedures (SOPs) Verify accuracy of data in source documentation and accuracy of transcription from source data Case Report Forms (CRF) as needed Ensure errors on source documents e
10 May 2025;
from:
gumtree.co.za