Job Description

Main purpose of the job:

• To implement pharmaceutical services as per protocols for clinical research studies conducted at Wits RHI research sites

Location:

• Wits RHI - 7 Esselen Street, Hillbrow, Research Centre - Johannesburg
• On the 3rd, 4th, and 5th Floor

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 the site
• Assist in the 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 them 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
• Take ownership and accountability for tasks and demonstrates effective self-management
• Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
• Maintain a positive attitude and respond openly to feedback
• Take ownership of driving your own career development by participating in ongoing training and development activities such as forums, conferences, policy-setting workshops, etc.
• Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization
• Promote harmony, teamwork, and sharing of information
• Comply with Good Clinical Practice (GCP), Protocol requirements, and Standard Operating Procedures (SOPs)
• Verify the 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.g., CRF are corrected, initialed, and dated
• Support the timely transmission/data faxing of relevant Case Report Forms following QC activity (as needed)
• Ensure completion of corrective action of internal and external QC reports and monitoring reviews
• Assist with staff training (and retraining) where error trends are identified

Required minimum education and training:

• Bachelor of Pharmacy Degree

Required minimum education and training:

• Minimum of 4 years experience in research of which two should be in a clinical trial or research environment

Desirable additional education, work experience, and personal abilities:

• A certificate in Good Clinical Practice (GCP) and a Valid driverxe2x80x99s license will be an advantage
• Good administration skills with working knowledge of Microsoft Office
• Able to work independently and as part of a multi-disciplinary team
• Self-starter and take initiative
• Patient, tactful, and empathetic toward participants
• Attention to detail
• Exceptional organizational and administrative skills are required together with working knowledge of Microsoft Office

TO APPLY:

• Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
• Please Apply Online.
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
• The closing date for all applications: 10 August 2023.
• Note AJ Personnel is fully POPI compliant.
• Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.

Please note:

• AJ PERSONNEL is only responsible for the advertising of the advertisement on behalf of their client Wits Health Consortium.
• Wits Health Consortium will only respond to shortlisted candidates.
• Candidates who have not been contacted within two weeks of the closing date can consider their applications to be unsuccessful.
• AJ Personnel does not have any salary or other information regarding the position.

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