Research Physician/principal Investigator

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**Core functions and purpose of the role**:
Direct and oversee all research activities of all allocated projects and foster a culture of research integrity. Responsible for administrative management research and conducting research in an objective and unbiased manner in compliance with policies and regulations. While the PI may delegate responsibility for some project activity to others, the PI is ultimately responsible for complaints with all applicable regulations, and policies, and for all aspects of the clinical trials (this includes the accurate, timely, complete, ethical, and efficient processing of study volunteers in accordance with the study protocol, procedure manual, and good clinical practice)

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- Conduct clinical trials as principal investigator
- Liaise with internal and external stakeholders for the specific clinical trials and with clients
- Ensure ICH GCP and all local guidelines are met
- Initiate and participate in the publication of trial data
- Oversee research study-related tasks, such as regulatory processes, recruitment and retention of participants, quality assurance processes, and laboratory and pharmacy processes.
- Recruit eligible participants into studies and consent participants
- Clinical management of participants as per protocols
- Attending and conducting training activities relevant to the specific clinical trial
- Attend site and sponsor training
- Laboratory result reviews and actioning
- Read and interpret ECGs
- Read and interpret CXRs
- Answer monitoring and data queries
- Assist with periodic reviews of SOPs and writing new SOPs as needed
- Assist with source document preparations
- Assist with data and source QC activities and ensure all data queries are handled
- Taking responsibility for reporting all adverse and serious adverse events
- Assist with community engagement activities and general community education, as required
- Provide training to colleagues
- Medical oversight of the study/studies
- Attend to clinic patients at the clinic
- Performance management of staff conducting the specific clinical trial

**Expected Areas of competence**:

- Be a registered doctor with MBChB and at least 2 years of experience in clinical research
- Current HPCSA registration
- Current medical malpractice insurance
- Good general knowledge of general medical practice and accompanying skills
- Good decision-making skills in patient treatment
- Have a thorough knowledge of ICH GCP
- Follow study protocols and SOPs at all times
- Exercise meticulous attention to detail in recording patient information and data, ensuring any queries are acted on in a timely and efficient manner
- Ensure all study documentation is completed, signed off and actions are completed
- Maintain a professional attitude towards colleagues and participants
- Communicate all decisions and actions with your colleagues, demonstrating a helpful and flexible approach
- Demonstrate proactive behavior to optimize the use of time
- Take ownership of own professional development by staying abreast of medical literature
- Proficiency in MS Word, Excel, and PowerPoint
- Previous research experience an advantage
- Proficiency in verbal Tswana and/or Zulu an advantage

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**Reference: Research Physician