Main purpose of the job: Ensures the quality of the respective study data by means of identifying irregularities through audits and provides solutions to rectifying the same Location: PHRU – Tshepong Hospital, Matlosana, Klerksdorp Key performance areas: Design and provide ethics and or PI with study documentation in line with study protocol as and when required Facilitate the review of site investigator files at least once quarterly ensuring all relevant documents and filed and maintained accordingly Document the internal monitoring findings and circulate to all relevant stakeholders including project managers and PI's Facilitate internal monitoring debrief sessions with the relevant stakeholders ensuring methods of correction are identified and set timelines for such corrections Prepare and timeously submit the relevant progress reports as required by sponsors in conjunction with the necessary stakeholders Identify laboratory result abnormalities and ensure that serious events are reported on the required SAE forms / processes in line with sponsors requirements Prepare an internal monitoring plan ensuring all protocols / projects are evaluated in line with sponsors requirements and project needs Conduct site initiation inspections as the project requires ensuring documented feedback is timeously provided to the relevant stakeholders Assist Project Team with the addressing and resolution of external monitors findings. Attend internal and external meetings required Conduct study close out meetings ensuring all respective data issues, monitoring issues, study documentation are dealt with in line protocol Identify training deficiencies with the team regarding QC requirements and facilitate 1-2-1 and group training required Train Study Coordinators of the projects thereby up skilling within QC Provide thorough orientation for new study employees until competency is determined Ensure that corrective action is issued in line with the code of conduct and in consultation with the HR department are required Ensure that leave is managed in accordance with to the leave policies Supervise and manage the duties of subordinates Ensure that all employees are developed to their full potential Provide sound coaching and empowering of the respective teams as skills needs and/or deficiencies are noted Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained Inform the relevant parties in the event of tasks or deadlines not met and provides appropriate means of resolution Required minimum education and training: Bachelor's Degree in medical science or health disciplines Computer literacy Good Clinical Practice Certificate Valid driver's license and able to drive Required minimum work experience: At least 2 years' research experience Experience in Quality control and assurance Desirable additional education, work experience and personal abilities: Excellent clinical skills and high attention to detail Ability to multi-task and to work in a complex and demanding environment Able to adhere to COMP and used tools to monitor the study Experience in training and capacity building Able to work independently and as part of a multi – disciplinary team Adaptable, willingly to take initiative Strong organization skills and excellent communication skills Communicate effectively with the Senior Management team, subordinates, and support staff as well as with all external stakeholders e.g. district and sub district teams, DOH, community, academic institutions It is expected that she will apply consistent adherence to research and GCP practices Working after hours may be necessary Being contactable after working hours Able to work in a highly pressured and challenging environment TO APPLY: Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV with a cover letter (Maximum one page) that clearly states which vacancy you are applying for. Please Apply Online and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate 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. AJ Personnel is fully POPIA Compliant. 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: 14 March 2024 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. 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 the advertisement on behalf of their client Wits Health Consortium. AJ Personnel does not have any salary or other information regarding the position. Empathy and sensitivity toward people from key populations Research experience or willingness to learn
