STUDY SUMMARY ICAP at Columbia University is currently conducting two federally-funded research studies that aim to improve the delivery of HIV services in resource-limited settings. The first study, START, is a cluster-randomized study that evaluates the impact of a combination of interventions aimed at improving ART initiation, adherence and completion during TB treatment among individuals co-infected with TB and HIV in Lesotho. The second study, ENRICH, is a cluster-randomized trial which aims to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among HIV-infected individuals enrolled in HIV care at health centers in Ethiopia. The New York-based project coordinator is a full time position with duties split equally between these two studies. POSITION SUMMARY Reporting to the Director of the Clinical & Training Unit with additional oversight provided by the Senior Research Director, the Project Coordinator, START & ENRICH is responsible for providing overall technical support with regard to study implementation including data management, enrollment tracking, study staff support and training, report writing and all study procedures at study sites located in Lesotho and Ethiopia. Works closely with research staff in the local ICAP offices and undertakes frequent visits to study sites to support study implementation, assess data collection practices and to ensure compliance with protocol standard operating procedures. Responsible for reporting all deviations from the study protocols as well as adverse events to the studies’ Principal Investigator and senior study staff. Conducts routine data quality assessments to ensure accuracy of data and provides additional training support as needed. Works closely with in-country Study Coordinators, study Co-Investigators to prepare reports to the studies’ Principal Investigator. MAJOR ACCOUNTABILITIES Supervise all study-related activities at designated study sites including management and ongoing technical support for all on-site study staff in Lesotho and Ethiopia. Oversee and assist with study implementation including review and revision of standard operating procedures, preparation of documentation for IRB submissions including modifications and annual progress reports, developing strategies for recruitment and retention, and providing on-going technical support to ensure continued implementation of the study. Provide weekly updates and communicate regularly with senior study staff to inform them of study progress and any challenges encountered at the sites. Assist in-country study coordinators to provide regular updates on the progress of the study to the health facility management and clinical care teams at study sites. Project Coordinator, START & ENRICH – 2 September 2013 Oversee data quality assurance for the study through routine data quality checks and on-site assessments as per study standard operating procedures. Oversee on-site data management for the study including facilitating submission of data from the on-site study team to New York offices. Oversee on-site adherence to the protocol and standard operating procedures for study procedures; ensure adverse event reporting to the studies’ principal investigator. Assist with data dissemination activities, including drafting the final study reports. Assist with other aspects of the study as directed. EDUCATION Masters degree in public health, health management information systems, statistics or related field. Significant and directly related experience may be substituted for the advanced degree. EXPERIENCE, SKILLS & MINIMUM REQUIRED QUALIFICATIONS Detailed knowledge and practical experience in health related research, including adherence to research protocols, data collection procedures and ethical requirements of human subjects research. Demonstrated expertise using Microsoft Office suite applications, including MS Access. Excellent communication, interpersonal, analytical, and organizational skills. Excellent writing and editing skills. Demonstrated experience working independently with limited supervision or as part of a team-based environment. EXPERIENCE, SKILLS & PREFERRED QUALIFICATIONS Experience managing and supervising a multisite research project, including managing study staff, overseeing data collection for a research project and conducting data quality assessments. Experience with international research studies. TRAVEL REQUIREMENTS Requires frequent travel to study sites in Lesotho and Ethiopia (approximately 6 trips per year) with each trip lasting one (1) to two (2) weeks
Posted on: Mon, 23 Sep 2013 15:11:10 +0000
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