Research Medical Officer

3 days ago


Johannesburg, South Africa AJ Personnel Full time

**Main purpose of the job**:

- To recruit, screen, and provide clinical management to participants in clinical trials according to study protocols

**Location**:

- **Wits RHI - 7 Esselen Street, Hillbrow, Research Centre**:

- **On the 3rd and 4th Floor**

**Key performance areas**:

- Clinical assessment, treatment, and/or referral of participants who participate in the study
- Participate in the routine assessment of participants in accordance with the protocols
- Initiate, maintain and strengthen referral systems via direct interaction and assist in the establishment of Memorandums of understanding (MOUs) as required by the study protocol/s
- Conduct regular liaison with the laboratory regarding the interpretation of diagnostic test results
- It is the responsibility of the clinician to ensure that an appropriate management plan is followed as a result of receiving diagnostic test results
- Management of Hepatitis B vaccinations of Research center staff and maintaining accurate records
- Screen and enroll eligible patients in accordance with the study protocol and ethical guidelines
- Review patient vitals and other study-related results
- Treat opportunistic infections diagnosed
- Prescribe the appropriate treatment
- Report any adverse events and follow-up on patients
- Conduct regular emergency trolley inventory, order/replace expired consumables
- Provide regular clinical support to the clinic staff to ensure that clinical management of participants is of high quality and complies with HPCSA and WITS RHI standards
- Data collection and storage of data according to GCP and study SOPs
- Recruitment and retention according to set accrual targets as required by the sponsors
- Development and ongoing revision of standard operating procedures compliant with sponsor and unit guidelines
- Identify research questions in a specialist area
- Implement research studies in conjunction with the research teams
- Attend, present and participate in organizational research and academic meetings
- Produce monthly progress reports which document clinical outcomes of study participants
- Complete source notes and patient logs
- Capture patient data on the Case Report Forms
- Attend meetings as required
- Engage and meet with sponsors and Monitors as required
- Attend to all staffing requirements and administration
- Supervise and manage the duties of subordinates to ensure optimal staff utilization and maintenance of sound labor relations
- Perform and facilitate performance development and assessments
- Identify substandard performance by team members and take necessary corrective action
- Coach and train subordinates and team members to ensure the acquisition of knowledge and skills required by the organization
- Promote harmony, teamwork, and sharing of information
- Take ownership and accountability for tasks and demonstrate effective self-management
- Follow through to ensure that quality and productivity standards of own work are consistently and accurately maintained
- Maintain a positive attitude and respond openly to feedback
- Take ownership of driving your own career development by participating in ongoing training and development activities such as workshops, forums, conferences, etc.
- Participate and give input in ad hoc projects and initiatives
- Comply with Good Clinical Practice (GCP), Protocol requirements, and Standard Operating Procedures (SOPs)
- Verify the accuracy of data in source documentation and accuracy of transcription from source data Case
- Report Forms (CRF) as needed
- Ensure errors on source documents e.g. CRFs are corrected, initialed, and dated
- Support the timely transmission/data faxing of relevant Case Report Forms following QC activity (as needed)
- Ensure completion of corrective action of internal and external QC reports and monitoring reviews
- Assist with staff training (and retraining) where error trends are identified
- Proactively resolve protocol queries and missing data with the Research Team

**Required minimum education and training**:

- **MBBCh degree or equivalent**

**Required minimum work experience**:

- **Minimum 3 years of which 1 should be in a research environment**:

- **Minimum 2 years of trial experience**

**Professional body registration**:

- Health Professions Council of South Africa (HPCSA)

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

- Experience working in a donor-funded organization
- Post graduate qualification in Public Health/HIV management or in the process of obtaining a qualification
- Experience in Reproductive Health
- Experience in writing donor proposals, protocols, and scientific journals
- Certification in HIV Management and good clinical practice
- Well-organized, ordered, systematic and analytical
- Working knowledge of Microsoft Office
- Assertive, confident, and adaptable
- Able to work under pressure and adhere to deadlines
- Self-motivated, able to work independently and work as part of a multidi



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