To assist with all regulatory and administrative duties to ensure the smooth running of the Prevent TB, FEDISA, and TUTTPT project
Location:
PHRU - Tshepong Hospital, Matlosana, Klerksdorp
Key performance areas:
Perform quality assurance activities
Provide training/escalation for corrective action for site staff based on QA, QC, and monitoring findings
Maintain site files
Track regulatory submissions and approvals and exercise version control
Oversee monitoring visits
Submit reports and track protocol deviations and significant study events including serious adverse events, and pregnancies
Plan and report on recruitment and retention
Create and actively manage visit schedules
Oversee recruitment and retention for assigned protocols
Oversee study closure and archiving when applicable
Maintain relevant documentation according to sponsor requirements
Conduct protocol, SSP, and SOP training for staff as required
Liaise with the Sponsor, Laboratory, Pharmacy, and external monitoring contractor
Required minimum education and training:
Post Matric Qualification (Diploma/Degree/Certification) in Healthcare (Enrolled Nurse) with Research experience
Good Clinical Practice (GCP) Certificate
Advanced MS Word, MS Excel, Outlook skills essential and Database Software e.g. RedCap
Driver's license and ability to drive
Required minimum work experience:
3 years experience in Research
RedCap and Research activities coordination
Compilation of reports
Professional body registration:
Registered with the South African Nursing Council as an Enrolled Nurse
Desirable additional education, work experience, and personal abilities:
Quality control, regulatory, and trial administrative experience
Able to exercise discretion and independent decision-making
Problem-solving abilities with an understanding of corrective and preventative action paradigms
Able to work under pressure
Flexible and able to work with a team
Training skills and responsive and responsible
Ability to communicate effectively within the study team and with external
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 January 2024.
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.
Apply
Company Description
The Perinatal HIV Research Unit (Wits PHRU) was established in 1996. The Perinatal HIV Research Unit has been involved in research, training, policy formation, and advocacy in issues concerning HIV-positive women and their children.
In recent years the work of the unit has expanded beyond the original focus of mother-to-child transmission of HIV.