To administer, maintain and coordinate clinical trials according to good clinical practice, the study protocol, and the site standard operating procedures
Act as a pivotal point of contact for the clinical trial team and the study sponsor(s)
Location:
27 Ridge Road, Parktown - Johannesburg
Key performance areas:
Study Management
Primary SSC on trial to oversee all operations on trial, ensure protocol and GCP compliance
Attend Investigator meetings, SIV, and any other in-person or virtual training to manage the study
Assist study team with efficient study start-up, conduct and close-out
Ensure access to online portals for self and support staff
Manage regulatory updates throughout the study (New ICFs, Protocol Amendments, etc.)
Manage site monitor visits according to GCP and Site SOP
Proactively resolve protocol queries and missing data with Investigators and Clinical Trials Assistants
Communicate with CRO, Sponsor, and regulatory authorities regarding notifiable trial events
Participant Management
Prepare for and manage participant visits and data capturing in line with protocol and site SOPs
Assist in patient recruitment, screening, and enrolment of eligible patients according to protocol requirements
Perform and/or book procedures correctly per protocol within the scope of practice
Manage lab kits and study samples according to protocol, procedures manual and local legislature within the scope of practice
Administer study medication safely in line with the scope of practice
Be able to manage medical emergencies within the scope of practice
Communicate well with investigators regarding participant welfare while on study
Notify relevant parties of Serious Adverse Events or Events of Medical Importance within 24 hours
Quality control of patient files and data entries (i.e., eCRFs, CRFs)
Teamwork & Support
Assist team members with an open helpful attitude, perform on-the-job training where necessary
Assist the Pharmacist with visit activities (IVRS, IP management, etc.)
Assist the administrative staff with arrangements to be made for participant visits (Patient transport with Uber, Vendor booking details, etc.)
Assist site finance staff with payments on the study (pass-through, travel fees, etc.)
Assist the team with ad hoc assignments and duties as needed, delegated by the line manager and within the scope of practice
Required minimum education and training:
Nursing Diploma with Oncology
Certification in Project Management and Good Clinical Practice (GCP) will be an advantage
Required minimum work experience:
Minimum 2 years of Oncology experience in a clinical trial environment
Professional body registration:
Registration with SANC
Desirable additional education, work experience, and personal abilities:
Thorough with good attention to detail
Ordered and systematic in approach to tasks, with strict compliance to protocols
Exceptional organizational and administrative skills are required together with working knowledge of Microsoft Office
Able to exercise discretion and independent decision-making
Ability to prioritize own workload, take initiative (pro-active) and work to tight deadlines
Self-motivated with 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 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: 22 August 2023.
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
Background
WITS CLINICAL RESEARCH (WCR) is a division of the WITS HEALTH CONSORTIUM (PTY) LTD, a wholly-owned subsidiary of the University of Witwatersrand in Johannesburg (South Africa) under the Wits Faculty of Health Sciences.
With WHC providing the core infrastructure, WITS CLINICAL RESEARCH is free to focus on conducting quality research in the fields of, amongst others, cardiology and cardiovascular risk factors.