1. PRINCIPAL RESEARCH OFFICER (RESEARCH REGULATION/ETHICS), JOB GROUP MR/13 (1 POSITION)

Job Closed!
Company:Kenya Medical Research Institute,
Category:Research
Job Type:Permanent
Salary:Ksh. NIL
Location:Nairobi

Job details

 

Position Description: - The holder of this position will be the Head of KEMRI’s Scientific and Ethical Review Unit (SERU) and will report to the Deputy Director (Research & Development). He/She will be responsible for provision of regulatory expertise for purposes of regulatory compliance and ensuring provision of efficient and timely review of research proposals.

 

 

Duties and Responsibilities:-

 

 

  • Responsible for the day-to-day administrative and regulatory operations at the Scientific and Ethical Review Unit (SERU).

 

  • Developing and implementing policies and procedures and in the design and implementation of projects and programs supporting SERU activities.

 

  • Providing analytical, technical and professional support to the Institutional Review Board.

 

  • Supporting all aspects of applicable regulatory compliance.

 

  • Ensuring optimal service to the research community and accurate compliance with relevant government and Institutional policies.

 

  • Advising investigators on compliance with Kenyan laws, regulations, policies and procedures related to human research participants' protection.

 

  • Ensuring maintenance of an up-to-date understanding of the national and international policies and regulations.

 

  • Participating in the development, design, and delivery of research ethics training for researchers, SERU members, and/or SERU Secretariat staff.

 

  • The Human subjects protection officer for the FWA.

 

  • Be responsible for mobilizing resources for SERU activities.

 

  • Providing oversight in the development and implementation of Monitoring and Quality assurance systems for SERU;

 

  • Providing training, day-to-day guidance and supervision of SERU Staff, research analysts and research administrators; and

 

  • Engaging in research on ethics / human subjects’ protection.

 

Requirements for Appointment:-

 

 

For appointment to this grade a candidate must have:

 

  1. 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;

 

  1. Master’s and PhD degree in any of the above fields;

 

  1. A higher qualification in research or Clinical ethics will be an advantage;

 

  1. Diploma in ethics or Certified IRB professional;

 

  1. Four (4) years or more in research management experience in a similar organization, membership in an ethics committee;

 

  1. Training in management for at least one month;

 

  1. Analytical skills to interpret data and present findings;

 

  1. Strong interpersonal skills and the ability to effectively work with a wide range of individuals and constituencies in a diverse research environment;

 

  1. Problem solving and decision-making skills;

 

  1. Ability to maintain confidentiality of SERU information and records;

 

  1. Meets the requirement of Chapter six of the Constitution of Kenya; and

 

  1. Ability to lead a team and to be a team player with strong mentoring and capacity building

 

skills.

 

  1. SENIOR RESEARCH OFFICER (RESEARCH REGULATION/ETHICS), JOB GROUP MR/12 (1 POSITION)

 

 

Position Description: -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 and Responsibilities:-

 

  • 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; 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:

 

  1. 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;

 

  1. Master’s and PhD degree in any of the above fields;

 

  1. Minimum of three (3) years’ experience in Research Regulation;

 

  1. Diploma in Research ethics/ Relevant Certificate training in Research ethics or Certified IRB professional;

 

  1. Skills in the use of personal computers and related software applications;

 

  1. Strong organizational skills and ability to manage multiple priorities;

 

  1. Ability to lead and operationally supervise staff;

 

  1. Meets the requirement of Chapter six of the Constitution of Kenya; and

 

  1. Knowledge of current and emerging legislative, policy, and operational issues and trends in the area of research compliance.

 

 

The following will be required during the interviews :- Certificate of good conduct, Higher Education Loans Board compliance certificate, KRA Tax compliance certificate, Credit Reference Bureau clearance certificate, Ethics and Anti-Corruption Commission clearance.

 

Interested candidates should submit their applications enclosing a detailed CV, copies of academic and professional certificates, email address, a day time telephone contact and the details and contact information for three referees to the following address, not later than 22nd May 2018 to:-

 

The Director,

Kenya Medical Research Institute,

P.O. Box 54840-00200, NAIROBI, (Attn: Assistant Director (HR))

 

KEMRI is an equal opportunity employer committed to diversity. Persons with disability, women, youth and those from marginalized areas are encouraged to apply.

 

Please visit the KEMRI web site www.kemri.org for more details on the advertisement.

 

Please write the Position applied for on the envelope and in the subject Line of the Application letter.

 

NB: Only shortlisted candidates will be contacted.

 

Click here to apply; https://www.kemri.org/index.php/careers

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