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Aj Personnel is seeking a Project Manager/Study Coordinator for the Wits Reproductive Health and HIV Institute in Johannesburg. Responsibilities include coordinating clinical trial activities, ensuring compliance with regulations, and managing the study team. The ideal candidate will have a health-related degree and experience in clinical trials, demonstrating strong organisational and communication skills.
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 :
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 or Honours Degree in a Health-Related Field
Required minimum work experience
3-5 years' experience in clinical trials / research
Desirable additional education, work experience and personal abilities :
Master's 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
TO APPLY :
Only if you meetthe 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
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 and subsequent amendments thereto
AJ Personnel isonly responsible for advertising and the response handlingon behalf of their client Wits Health Consortium
AJ Personnel does not have any salary or other information regarding the position
Project Coordinator • Johannesburg, Gauteng