Title: GAP Combination Prevention Study/Clinical Intervention Technical Advisor
Period of Performance: March 26, 2016 - September 14, 2016
Place of Performance: Gaborone, Botswana
Service Objectives
Under this task order, the contractor will independently provide all labor, supplies, material and equipment (exceptions noted below) in support of the Centers for Disease Control and Prevention (CDC) and the Presidential Emergency Plan for AIDS Relief (PEPFAR) partner s in accordance with this Statement of Work in support of CDC by providing the following services:
Task Requirements
The Clinical Intervention Technical Advi sor coordinates and oversees all clinical intervention activities at the Ministry of Health clinic sites involved in the BotswanaCombination Prevent ion Project (BCPP) which is implemented by the Centers for Disease Control and Prevention- Botswana. The main function of the incumbent is to monitor and evaluate performance of the BCPP study sites on the implementation of the clinical portions of the combination prevention package as out lined in the research protocol. The Clinical Intervention Technical Advisor serves as a co-investigator on the project , assists in protocol writing and amendment s and implementation of the project across all communities involved in the study; the incumbent will be responsible for monitoring study implementation at the study clinics including the day-to-day procedural activities of the study. The components of the combination prevention package under the oversight of the Clinical Intervention Technical Advisor include, butare not limited to: linkage to care, HIV treatment and care, PMTCT, adherence and retention in care and safe male circumcision. The Clinical Intervention Technical Advisor is responsible for ensuring that the research project is conducted in accordance with US federal regulations, Botswana regulations , good clinical practice standards, and any provisions imposed by the Botswana Health Research Development Committee (HRDC) and the CDC Institutional Review Board (IRB). The position requires strong collaboration with the Ministry of Health's study personnel for the preparation, operation and monitoring of study clinics. Other key partner s are Tebclopele Voluntary Counseling and Testing Centers and JHPIEGO.
To ensure that the protocol is being implemented accordingly, the Clinical Intervention Technical Advisor will develop appropriate monitoring and evaluation tools, standard operating procedure s (SOPs) and procedures manual s for use in the field. The incumbent will also be responsible for training, mentoring and overseeing staff implementing the clinical portions of the study. In liaison with Regional Research Nurses and MoH clinical personnel (BCPP Coordinator, Chief Medical Officers), the incumbent monitors all study sites for compliance with study protocols and Botswana National Guidelines to ensure success of the project. Prior to site roll out, the incumbent will liaise with Ministry of Health officials to prepare clinic sites for site activation and initiation visits. The incumbent will also oversee day-to-day running of study clinics to ensure that matters relating to study performance are dealt with forthwith. The incumbent will support quality assurance and monitoring activities by identifying problem s and introducing solutions, thereby ensuring best practices are replicated across study clinics.
The Clinical Intervention Technical Advisor is also responsible for reporting on adverse events, protocol deviation s and other incidents occurring at the stud y sites. He/She will provide weekly reports from study sites as part of the monitoring process for the project and prepare sites for internal and external monitoring. The Technical Advisor will al so be responsible for report writing regarding interim data analysis and reporting as required by the study principal investigators.
Minimum Qualifications and/or Certifications
- Education:
MD, (equivalency accreditation if a non-US institution) and a Master’s in Public Health (MPH) and clinical research training with strong monitoring and evaluation or epidemiology back ground.
- Prior work experience:
At least five years of progressively responsible work in clinical medical research, monitoring and eva luation, epidemiological research, or related medical research. Experience working in developing countries is an advantage. Clinical HIV management background desirable.
- Post entry training:
May be required to undergo further training in epidemiology, clinical or operational research, health service planning, program implementation and evaluation
- Language proficiency:
Must speak and understand spoken English fluently (level TV): including ability to read and understand technical documents and journals, and write letters, administrative and technical reports and scientific paper s for publication in English language journals.
- Know ledge:
Knowledge of principles and practices of epidemiologic, biomedical, or relatedscientific research, including facility with surveillance, research design concepts and basic statistical methods and procedures. Must possess the sensitivity and maturity to deal with HIV issues. A demonstrated ability to work effectively with person s at all levels of the public health system is required. Excellent communication skills are required.
HOW TO APPLY:
Interested candidates should email their cover letter and CV to resumes@ctsglobalusa.com
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