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; and
Representing SERU at various internal and/or external institutional fora, as appropriate.
Requirements for Appointment:-
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 Constitution Kenya;
Knowledge of current and emerging legislative, policy, and operational issues and trends in the area of research compliance.