Senior Research Officer at Kenya Medical Research - KEMRI

JOB GROUP MR/12

The primary role of this position is to provide leadership within Scientific and Ethics Review Unit (SERU) – (Research Regulation/ Quality control and Mentoring/Training).
Duties for the Senior Research Officer Job

• Serve as Secretary to SERU committee;
• Reviewing and analyzing scientific, technical and ethical components of research proposals;
• Advising investigators on adherence to/compliance with mandated Kenyan laws, regulations, policies and procedures related to human research participants’ protection;
• Coordinating and conducting expedited review of proposals;
• Carrying out site monitoring and other regulatory activities for various studies reviewed at SERU to ensure compliancy.
• Coordinating the activities of analysts and/or administrative support staff, as appropriate;
• Advising and guiding research investigators with respect to the proposal development and documentation necessary to ensure compliance with provisions pertaining to human research participant protections in biomedical and clinical research;
• Attending SERU meetings and providing technical support and guidance on regulatory matters; records medical and ethical issues discussed, and ensures accurate documentation of final committee determinations;
• Ensuring maintenance of an accurate and comprehensive database of reviewed and approved research.
• Reviewing clinical research applications, safety reports, DSMB reports and advises the SERU on matters requiring their attention and creates a safety report database and generates monthly technical reports.
• Maintaining up-to-date understanding of the national and international policies and regulations;
• Executing audits of clinical research projects;
• Reviewing research and medical records and processes as appropriate to assess compliance with proposals, regulatory requirements, and guidelines;
• Participating in the development, design, and delivery of research ethics training for researchers, SERU Committee members, and/or SERU Secretariat staff;
• Engaging in Monitoring and Quality assurance activities for SERU;
• Providing training, day-to-day guidance and supervision to research administrators;
• Representing SERU at various internal and/or external institutional fora, as appropriate.

Job Requirements

For appointment to this grade a candidate must have:

• Bachelor’s degree in any of the following fields;- Medicine, Dentistry, Veterinary Medicine, Pharmacy Biomedical Sciences, Public Health or any relevant Social Science, or equivalent qualifications from a recognized Institution;
• Master’s and PhD degree in any of the above fields;
• Minimum of three (3) years’ experience in Research Regulation;
• Diploma in Research ethics/ Relevant Certificate training in Research ethics or Certified IRB professional;
• Skills in the use of personal computers and related software applications;
• Strong organizational skills and ability to manage multiple priorities;
• Ability to lead and operationally supervise staff;
• Meets the requirement of Chapter six of the Constitution of Kenya; and
• Knowledge of current and emerging legislative, policy, and operational issues and trends in the area of research compliance.