Job Description

Job Summary Location:

• Chris Hani Baragwanath Academic Hospital (main site) & Helen Joseph Hospital - Johannesburg

Key performance areas:

• Contribute to the development of study documentation including protocols, patient information sheets and consent forms, SOPs/WPDs, quality assurance and quality control guidelines and training manuals
• Compile source notes and recruitment tools
• Participate in regular meetings between the clinical teams at the sites and ensure good communications between sites and the management group
• Maintain close contact with the study management group and consult them on strategic issues that might have any safety or major financial implications for the project. This will include, but not be limited to, collation of weekly reports of study progress to be shared with the study management group
• Conduct clinical study in accordance with GCP regulations and standard operating procedures
• Proactively resolve protocol queries and missing data with the study Management Group
• Cover duties of the COMBAT trial study team during staff leave periods
• Assist in all clinical aspects of the study, including venepuncture, cannulation, blood sample processing, drug administration and clinical observation when necessary
• Oversee clinical procedures including dispensing of related drugs to study participants and other protocol related procedures, with the study nurses and pharmacists
• Screen and enroll patients in accordance with the study protocol and ethical guidelines
• Obtain participants informed consent before commencement of any study related activities
• Conduct any pre-study entry medical evaluation for potential participants & offer daily clinical care to study participants, with the study doctor. S/he should also ensure that patients who need referral to other health care services are duly referred
• Maintain confidentiality of all participants study information
• Review patient vitals, X-rays, echocardiograms, scans and other study-related results
• Report any adverse events and ensuring appropriate action is taken until a final report is completed
• Study the full history of referred patients from other clinics and discuss the relevant risk factors
• Monitor and evaluate the quality of care and counselling conducted at the study site(s) and assess findings with the team
• Perform spot check evaluations to quality control clinical source notes and CRFs
• Monitor the Study Recruitment/Retention Plan including planning meetings to address challenges of study enrolment and participant retention
• Play a supervisory role for the study clinical and nursing teams to ensure that; teams adhere to the set standard operating procedures in the conduct of clinical trials and that all staff are full trained in the SOPs pertaining to their daily work; data collection process is enhanced for quality with quality control measures in place; recruitment/accrual targets are being met; proper source documentation procedures are followed
• Manage the duties of the clinical study site team
• Identify study specific training needs and consequent provision of training in liaison with the Trial Ops Manager for study staff during study implementation
• Conduct staff training i.e. CRF completion training, quality assurance and other study related training
• To act as a leader, resource and role model
• Performs any other duties as assigned by the Site PI, Senior Research Clinician and/ or CI

Required minimum education and training:

• MBBCh Degree
• HPCSA Registration
• Certification in Good Clinical Practice (GCP)
• Project management qualification will be an advantage

Required minimum work experience:

• Minimum 1-year work experience, preferably in a Clinical Research environment

Desirable additional education, work experience and personal abilities:

• Displays serious concern for the safety and well-being of patients
• Ability to function and operate strategically with sound clinical acumen
• Confidentiality, tact and discretion must be always maintained
• Thorough, with good attention to detail
• Ordered and systematic in approach to tasks, with strict adherence to protocol
• Exceptional planning and organizational skills are required together with working knowledge of Microsoft Office and Email
• 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 a high regard for work ethic, values and integrity

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: 03 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.

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