Background:
- The Wits Reproductive Health and HIV Institute (Wits RHI) is a renowned African-led research institute that seeks solutions to Africa’s health challenges
- It is located within the University of the Witwatersrand and addresses some of the greatest public health concerns affecting our region, including HIV and its related problems, sexual and reproductive health, and vaccinology
Main purpose of the job:
- The project manager/study coordinator is responsible for coordinating all clinical trial activities according to good clinical practice, the study protocol and the site standard operating procedures
Location:
- Wits RHI – Lejweleputswa (Free State)
Key performance areas:
- Oversee all operations in the clinical trial to ensure protocol and GCP compliance
- Assist study team with efficient study start-up, conduct and close-out
- Manage regulatory updates throughout the study (New ICF’s, Protocol Amendments, etc.)
- Proactively resolve protocol queries and missing data with Investigators and Clinical Trials Assistants
- Communicate with CRO, Sponsor and regulatory authorities regarding notifiable trial events
- Prepare for and manage participant visits and data capturing in line with protocol and site SOP’s
- Perform and/or book procedures correctly per protocol within scope of practice
- Assist in patient recruitment, screening, and enrolment of eligible patients according to protocol requirements
- Compliance to all relevant SOPs
- Communicate well with investigators regarding participant welfare while on study
- Notify relevant parties of Serious Adverse Events or Events of Medical Importance as per protocol requirements. Quality control of patient files and data entries (i.e., eCRF’s, CRF’s)
- Attend Investigator meeting, SIV and any other key meetings to manage the study
- Manage site monitoring visits/audits or similar
- Manage procurement for the study
- Assist team members and support teams with an open helpful attitude, perform on-the-job training where necessary
- Assist the team with ad hoc assignments and duties as needed, delegated by line manager and within scope of practice
- Manage and support staff members
Required minimum education and training:
- Degree in Health-Related Field
Required minimum work experience:
- 3-5 years’ experience in clinical trials/research
Desirable additional education, work experience and personal abilities:
- Masters degree in a health-related field
- Work experience in sexual and reproductive health care
- Experience in Network studies
- Thorough with good attention to detail
- Valid driver’s license
- Ordered and systematic in approach to tasks, with strict compliance to protocols
- Exceptional organisational and administrative skills are required together with working knowledge of Microsoft Office
- Able to exercise discretion and independent decision-making
- Ability to prioritise own workload, take initiative (pro-active) and work to tight deadlines
- Self-motivated with a high regard for work ethic, values, and integrity
- Overtime and traveling will be required from time to time
- Light physical activity required
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: 07 March 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.
Desired Skills:
- Degree in Health-related field
- Clinical Trials experience
- Research experience
- Good Clinical Practice