Job Description

Job Summary 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.g., CRFs are corrected, initialled, 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

Professional body registration

• South African Pharmacy Council

Required minimum work experience

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

Desirable additional education, work experience and personal abilities:

• A certificate in Good Clinical Practice (GCP)
• Valid drivers 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 towards participants
• Attention to detail
• Exceptional organizational and administrative skills are required together with working knowledge of Microsoft Office
• 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 for driving 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 organisation
• Promote harmony, teamwork and sharing of information

TO APPLY:

• Only if you meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV
• Please Apply Online and complete your registration via our website to enable and protect you as a candidate, and to accept the new POPIA terms and conditions
• This will then create your permanent profile with which you can apply for all jobs as advertised by AJ PERSONNEL
• However, you may remove your profile from AJ PERSONNEL when you are no longer in the job market
• Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position
• 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
• Closing date: 19 May 2025
• Note: No CV will be accepted after the closing date

Please note:

• WHC, in accordance with its 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
• AJ Personnel is only responsible for advertising and the response handling on behalf of their client Wits Health Consortium
• AJ Personnel does not have any salary or other information regarding the position

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