Medical Officer

4 months ago

Durban, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To lead the clinical trial site(s) team, manage day-to-day activities of the trial site(s), and to provide health care to patients participating in the EFFECT clinical trial (Mycology Unit) according to the study protocol and contribute to the data analysis and any peer-reviewed publications arising from the study, and to contribute to related sub-studies or projects

**Location**:

- **King Edward VIII Hospital - Durban, KwaZulu-Natal**

**Key performance areas**:

- Clinical trial management_
- Contribute to the development of study documentation including trial protocols, patient information sheets and consent forms, SOPs/ WPDs, quality assurance and quality control guidelines, and training manuals
- Undertake recruitment of eligible patients according to protocol requirements
- Maintain close contact with the trial 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 trial management group and funders, and detailed reports for the Data Monitoring Committee and Trial Steering Committee
- Conduct clinical trials in accordance with GCP regulations and standard operating procedures
- Proactively resolve protocol queries and missing data with the Trial Management Group
- Patient Care and Screening_
- Assist in all clinical aspects of the study, including venepuncture, cannulation, blood sample processing, drug administration, and clinical observation when necessary, ensuring that they are carried out within the Hospital’s and Sponsor’s policies, research governance, Medicines for Human Use (Clinical Trials Regulations) Regulations 2004 and Amended Regulations 2006 Incorporating International Conference on Harmonisation of Good Clinical Practice (ICH GCP) Data Protection Act and Human Tissue Act
- Quality Assurance_
- Monitor and evaluate the quality of care and counseling 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
- Conduct regular site team meetings to identify, discuss and solve study queries
- Meet with Trial Monitors as and when required
- Staff Management_
- 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 fully 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

**Required minimum education and training**:

- **MBBCh Degree**

**Required minimum work experience**:

- **Minimum 1-year work experience, preferably in a clinical research environment**

**Desirable additional education, work experience, and personal abilities**:

- Registered with HPCSA
- Certification in good clinical practice (GCP)
- Project management qualification will be an advantage
- 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
- Able to exercise discretion and independent decision-making
- Ability to prioritise own workload, take initiative (pro-active) and work to tight deadlines

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- 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.**:

- **AJ Personnel does not have any salary or other information regarding the position.

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