Job Description

Main Purpose of the job:

• To strategically manage and lead the clinical trial team and activities and to provide health care to patients participating in clinical trials according to study protocols.

Location:

• PHRU, Omnipark Block 1, Aeroton, Johannesburg South.

Key Performance Areas:

• Strategically assess protocol synopses and the capability of the trial site to conduct studies.
• Conduct study feasibilities and risk assessment's
• Strategically plan clinical trials (forecasting, resourcing, timelines and baseline recruitment).
• Compile source notes and recruitment tools.
• Undertake recruitment of eligible subjects according to protocol requirements.
• Actively engages with sponsors and attend project meetings, as and when required.
• Plan, implement and complete the clinical research activities for clinical trials.
• Conduct clinical trials in accordance with GCP regulations and standard operating procedures.
• Proactively resolve protocol queries and missing data with Study Coordinators and/or Clinical Trials Assistants.
• Devise systems and processes to ensure effective and efficient study conduct (where applicable
• Screen and enroll patients in accordance with study protocol and ethical guidelines.
• Provide medical care to patients.
• Review patient vitals, echocardiograms, scans and other study-related results.
• Report any adverse events.
• Study the full history of referred patients from other clinics and discusses the relevant risk factors.
• Perform spot check evaluations to quality control clinical source notes and CRFs.
• Conduct regular clinical team meetings to identify, discuss and solve study queries.
• Meet with Monitors as and when required and analyse reports.
• Manage the duties of the clinical trial study and team.
• Attend to all staffing requirements and administration (including staff structures).
• Perform and facilitate performance development and assessments in conjunction with the Site Manager/CRS Leader.
• Ensure that all employees are developed to their full potential.
• Conduct staff training i.e. CRF completion training, quality assurance and other study related training.
• Assist the team with ad hoc assignments and duties.

Required minimum education and training:

• MBChB/MBBCh degree.
• Certification in good clinical practice (GCP), project management will be an advantage.

Required minimum work experience:

• At least 3-5 years' experience in a clinical research environment.

Worked as a principal or sub-investigator on 2 completed clinical trials.

1 year's working experience in using spreadsheet and database software.

Professional Body Registration:

• Registration with HPCSA

Desirable additional education, work experience and personal abilities:

Displays serious concern for the safety and wellbeing of patients.

Ability to function and operate strategically with sound clinical and business acumen.

Displays sound systems development and analysis skills.

Confidentiality, tact and discretion must be maintained at all times.

Thorough with good attention to detail.

Ordered and systematic in approach to tasks, with strict adherence to protocol.

Exceptional planning and organisational skills are required together with working knowledge of Microsoft Office. Able to exercise discretion and independent decision-making.

Ability to prioritise own work load and those of clinical team members, 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 do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
• Please Apply Online and complete your registration on Ditto Hire (our application tracking system) to enable and protect you as a candidate 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.
• AJ Personnel is fully POPIA Compliant.
• 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: 19 February 2024
• 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.

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 the advertisement 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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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.

AJ Personnel