The SAMRC’s HIV Prevention Research Unit (HPRU) seeks to appoint a Regulatory and Quality Manager with a strong background in either Medical, Biomedical or Epidemiology research.
supporting the development of new funding proposals; and leading regulatory and quality aspects of scientific papers, reports and policy briefs.
Additionally, she / he will support existing biomedical projects and will be expected to lead her / his own area of research.
The HIV Prevention Research Unit (HPRU) conducts research to prevent the sexual acquisition of HIV in vulnerable populations, in particular women and girls.
The Unit is involved in researching biomedical prevention strategies. The Unit is based in Durban, KwaZulu-Natal, and collaborates with key stakeholders in HIV / AIDS prevention research in South Africa as well as internationally.
We are looking for a dynamic, established Regulatory and Quality manager to enhance the research portfolio in HIV prevention.
Responsibilities : Regulatory and Quality Management : Provide oversight for adherence to NIH and clinical research network policies and procedures especially as they relate to regulatory issues, quality control and quality assurance.
Ensure the implementation of all Unit protocols according to GCP, SOPs and local regulations. Give presentations about the regulatory and quality aspects of HPRU supported studies, and / or other research at HPRU at local, national and international meetings, workshops and conferences Manage the Regulatory and Quality aspects of multiple studies and sub-studies daily, to ensure required outcomes are delivered.
Project Management : Achieve quality outputs within stipulated timeframes, this includes all regulatory and quality aspects of protocol activation, staff training, protocol implementation, minimal quality assurance and quality control issues, no protocol violations.
Manage individual projects as PI or Co-investigator. Provide input on protocol development, protocol revisions, and SOPs as required and ensure that staff are trained on updates.
Manage staff in the Regulatory and Quality Department, including performance management, research process management, leave approval, discipline, career development, staff training.
Scientific Output : Publish in ISI peer reviewed journal articles Income generation through grants and contracts Contribute to the HPRU grant writing processes.
Develop and lead the writing of research proposals for grant applications Staff capacity development, Masters or Doctorate-level student supervision or training, mentoring, training course facilitation provision Core Requirements : Master’s degree in Biomedical Science, Social Science or relevant health related discipline A minimum of 8 years senior research management and clinical trials experience is required, preferably in a research institution or a university Ability to manage the Regulatory and Quality aspects of multiple studies and sub-studies Experience in design, implementation, analysis, interpretation and reporting of Medical, Biomedical or Epidemiological research Proficient understanding of basic qualitative and / or quantitative research methods Experience in writing scientific reports and other forms of knowledge translation Experience in multi-disciplinary collaboration.
HIV co-morbidities; or clinical trial implementation, design and analysis A track record in undertaking and initiating original research Proficiency in a quantitative or qualitative analysis package (e.
g. STATA, SPSS, SAS, NVIVO) Successful grant application record Experience working on multiple NIH funded studies and with different clinical research networks Experience with submissions to local regulatory authorities PLEASE QUOTE THE REFERENCE NUMBER (R352A) IN ALL COMMUNICATIONS Interested candidates can send their CV