Reports to: Medical Director, Africa
The Role
The position has the following key responsibilities:
Integral part of the IAVI team responsible for Clinical Research Center (CRC) support and the conduct of observational studies and clinical trials
Under guidance of Director of Epidemiology provides training and support to collaborating CRC investigators and teams in;
The development of study protocols related to HIV and other infectious diseases epidemiology, pathogenesis and immunology, and related topics, including intervention studies.
Statistical design, data analysis and manuscript writing including report writing for research protocols. This may include conducting on-site training programs for CRC teams.
The use the Data Warehouse to access and analyze cross-network data.
Works with Director, Epidemiology to direct and support the design of observational studies projects, including socio-behavioral research and any other studies in collaboration with the Chief Medical Officer, Director Socio-behavioral Research, Medical Director – Africa, CRC investigators, IAVI staff and consultants.
Monitors CRC performance in the execution of observational studies, develops plans to improve CRC performance and capacity and ensures the internal and external approval, implementation of timelines and deliverables, and appropriate reporting of data and budget status are implemented.
Assists Director, Epidemiology with the IAVI Investigator Initiated Research and International Training Program activities including scientific manuscript writing program.
Collaborates with Director, Epidemiology, Chief Medical Officer, Medical Director – Africa, Clinical Program Managers, and Laboratory staff to ensure a seamless flow of information and direction to study CRCs.
Serve as a member of the EpiVACS (Epidemiology for Vaccine Advancement, Capacity and Science) team,
Supports the development of clinical trial CRCs using good clinical and good laboratory practices in collaboration with CRC investigators, governmental and non-governmental organizations and other internal IAVI resources.
Assists CRCs to:
Develop plans to recruit and retain suitable populations for clinical trials for HIV prevention research
Define procedures for collecting, analyzing and reporting relevant clinical and epidemiology data to support the inclusion of a cohort in above clinical trial
Supports internal IAVI staff in analysis and manuscript writing
Publishes regularly, at least annually as first or senior author.
Collaborates in evaluating and implementing the broader regulatory, social, political and communications environment that may affect CRC development, protocol review and approvals, recruitment, retention and data management
Other relevant duties as assigned.
Experience and Skills:
Advanced degree, preferably PhD in medical epidemiology or biostatistics relevant to HIV or STD prevention or treatment or the development of pharmaceutical products. An MD with masters in epidemiology or biostatics may be considered based on extensive experience and proven track record.
Minimum of 2 years of direct experience in preparing for and executing clinical trials or studies in resource poor settings. Knowledge of and experience with implementation of Good Clinical Practices in clinical trials conduct is desirable.
Relevant experience working in developing countries, especially Africa.
Proven success in the development and implementation of epidemiological studies or CRC preparation activities for clinical trials, particularly in developing countries.
Strong interpersonal relations skills, excellent judgment, proven ability to present programs to diverse audiences ranging from high level political to lay community groups.
Strong organizational skills, resourceful and mature self-starter, with proven experience in building a strong, coherent program and operations
Ability to operate within a scientific, social, medical or clinical research program settings
Willingness to travel at least 20% of the time and provide on-site support and training to CRC partners.
Publication record in peer reviewed journals.
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