Senior Assistant - Research Ethics, Senior Assistant - Research Ethics at Aga Khan University Hospital

Job Summary

The Senior Assistant - Research Ethics will be the primary point of contact for researchers submitting their research proposals for review to the Institutional Scientific and Ethics Review Committee (ISERC) with special focus on submissions for clinical trials. The Senior Assistant - Research Ethics will ensure that all protocol submissions by principal investigators are in line with policy requirements for ethics review. He/she will report directly to the Research Administration Manager.

Responsibilities 

• Support the Institutional Scientific and Ethics Review Committee (ISERC) in processing submissions of proposals, serious adverse events, study deviations, study violations ensuring timely processing of feedback to principal investigators.
• Support the ISERC monthly meetings by writing minutes of meetings and processing Principal Investigators’ feedback on their clinical trials.
• Ensure that the Aga Khan remains in full compliance of relevant laws and policies governing the conduct clinical trials in Kenya and globally.
• Support the Monitoring of Ethical Compliance of Research (MERC) for all research studies going on at the Aga Khan University.
• Support the Research Administration Manager in processing requests for review of Data Transfer Agreements and Material Transfer Agreements and ensure that all approvals are reviewed by the ISERC.
• Support the Research Administration Manager in ensuring that all approved research work seeking export of biological materials have the ISERC approval and that relevant documentation regarding export, use and disposal of research data and materials are adhered to and reported to the ISERC.
• Support research compliance functions around risk assessment and oversight, training and monitoring of ongoing Research by funders, National Commission for Science Technology and innovation (NACOSTI), National Research Fund and external entities as may be required.
• Support the members of faculty, residents and staff in submitting their proposals and documents on Infonetica – the Ethics Review Management platform.
• Assist the Research Administration Manager in development of forms, manuals and software upgrades for the Research Ethics Manager Software (INFONETICA) to increase efficiency in the processing of research ethics approvals.
• Perform any other duties as may be assigned by the Research Administration Manager from time to time.

Requirements

• A Bachelor’s degree in Bio-Medical research, BSc or health related field
• Post graduate diploma in Public Health, Project Management or related field will be an added advantage
• Completion of a course in research bio ethics, Good Clinical Practice or Responsible Conduct of Research would be added advantage
• Minimum of three years of work experience in a busy research organization or academic institution supporting active implementation of a health research project
• Experience in supporting the work of an ethics committee
• Working competence with MS Office Suite packages
• Good reports writing skills
• Excellent working skills in data bases such as Ms. Excel and Ms. Access
• Experience working with various research management software such as Pure research software, Infonetica, RHInnO or Omni star ethics management software

Personal Characteristics and Behaviour

• Personal commitment to high integrity and professionalism
• Organized and able prioritize tasks
• Good interpersonal and communication skills