Research Regulatory and Monitoring Officer ( FULL TIME )
Background:
The mission of the Infectious Diseases Institute (IDI) is to build capacity of health systems in Africa for the delivery of sustainable, high quality care and prevention of HIV/AIDS and related infectious diseases through training, research, and advanced clinical services. IDI has four operational areas through which it works to achieve its mission: Prevention, Care and Treatment; Training, Research; and Laboratory services (provided through a partnership with the Makerere University-John Hopkins University Core Lab). So as to strengthen support to these core areas of operation, IDI is recruiting Research Regulatory and Monitoring Officer as follows:
Role Summary and Responsibilities:
The Research Regulatory Officer is in charge of enforcing adherence to research guidelines for all the studies conducted at the institute including the research approval process, standard operating procedures (SOPs) and monitoring of studies.
Responsibilities:Policies and ProceduresAssists with the development and implementation of written research policies and procedures that foster compliance and excellence in research.Proposes changes in IDI research policy in response to changing needs of the organization.Liaise with the Uganda National Council for Science and Technology and other Ethics Committee to ensure that research at IDI is conducted in line with set standardsMonitors any developments in research national policy and brings them to the attention of the IDI Scientific Review CommitteeWorks with the Research Administration office to enforce research related policies and proceduresTraining
Assists with development and implementation of the research compliance education and training program for all research staff and students, including regulatory processes, protection of subjects, and responsible conduct of researchEnsure GCP compliance for research study staff and that this is periodically renewedCommunication
Develop and support effective systems of communication to ensure that issues relating to research compliance are effectively resolvedRespond promptly to detected compliance problems by working with impacted study teams to develop corrective actionCoordinate reporting any research compliance discrepancies to the appropriate institutional review committee and the Uganda National Council for Science and TechnologyCompile reports on the status of research compliance as may be requiredMonitoring
Lead internal research monitoring and auditing relating to research complianceEnsure that studies have standard operating procedures in placeDocumentation
Ensure that documents for completed research studies are archived according to internationally acceptable research standardsMaintain a central file containing stamped copies of study protocols and consent formsCreate systems for ensuring that study approvals remain currentOther
Offer support to the clinical trials unit.Assist in the development of research protocols where necessary.Assist in. other aspects of conducting studies as may be required.Performs any other reasonable duties as may be requestedRequirement:Educational Qualifications and experience
A Bachelors degree in a health related field.Knowledge, Abilities and Skills:
Computer and internet literateExcellent understanding of regulatory and monitoring issuesExcellent interpersonal skillsStrong interest in ResearchExcellent oral and written communication skills in EnglishExcellent interpersonal skillsHighly responsible about completing work assignmentsCan work independently and as part of a teamKnowledge of ICH-GCP guidelines and implementationAbility to organize, prioritize and schedule assignmentsKnowledge of the Ugandan scientific research regulatory processPrevious experience as part of a research teamGCP trainingCompensation for the positions will be commensurate with training and experience.How to apply:Qualified and interested persons may apply online on at hr@idi. co.ug OR email an application letter with a detailed CV, naming at least two professional referees to: The Human Resource Manager Infectious Diseases Institute P. O. Box 22418, Kampala. The closing date for applications is 2012. Only shortlisted candidates will be contacted.
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