Research Administrator
Vacancy No.
CGHR/218/10/21
Program description:
This program is collaboration between the Kenya Medical Research Institute and
the US Centers for Disease Control and Prevention (CDC) whose mandate is to conduct
research in malaria, HIV, TB,
and other diseases. To effectively carry out its mandate, the Family Health
Unit (FHU) is seeking to fill the position of a Regulatory Officer within
Family Health Unit.
Qualifications
- Bachelor of Science Degree nursing, social
sciences or a health-related discipline
- Experience in Regulatory Affairs/Quality Assurance
- Training on Regulatory Affairs/Quality
Assurance/Clinical trials will be an added advantage
- Fluency in Kiswahili and English – both written
and oral
- Training in Good Clinical Practice (GCP) and other
applicable regulations.
Skills and abilities
- Excellent interpersonal and organizational skills
- Attention to details,
- Ability to work with minimal supervision
Position Description:
The Regulatory Officer will report the Family Health Unit Head and will be
responsible for ensuring that studies within FHU are conducted in the highest
standards possible as per the specific study protocols, SOPs, GCP and all the
applicable regulations. S/he must be flexible, keen to details, strict on
timelines, have vast knowledge of the applicable regulations to the conduct of
clinical research and work within the existing structure, in a professional and
ethical manner with competence, accountability and integrity.
Responsibilities
- Maintain studies’ compliance with applicable
guidelines and regulations as well as all relevant local laws. at all
times.
- Keep track of all FHU protocols at the various
IRBs and the regulatory body with an aim of ensuring strict adherence to
submission/reporting timelines.
- Maintain documents as required by regulatory
agency guidelines.
- Organize, coordinate, and document all training
undertaken in respect to the study and to file all the relevant training
records.
- Conduct periodic internal monitoring and audits of
studies within FHU to ensure compliance with the protocol, SOPs, GCP and
all the applicable regulations.
- Assist in conducting periodic internal monitoring
activities for studies within FHU
- Tracking, documenting, and reporting adverse
events
- Training of staff on quality assurance issues.
- Writing and reviewing of Standard Operating
Procedures.
- Developing of study source documents.
- Any other duties assigned by the immediate
supervisor.
Terms of Employment:
- Terms of Employment: One (1) year renewable contract
as per KEMRI scheme of service and a probation period for the first 3
months.
- Remuneration: Compensation is as per the stated
salary scale, which is based on academic level, relevant experience and
demonstrated competency.
How to Apply
Applications are due no
later than: November
22, 2021 Interested candidates who meet the above criteria
are encouraged apply to: The
Deputy Director, CGHR, P. O. Box 1578- 40100, Kisumu or
submit via email address cghr@kemri.org.
Indicate the vacancy number in the subject headline
Application Documents
- Letter of application (Include vacancy)
- Most current CV with names of at least 2 referees
- Copies of academic and professional certificates
- Copy of Certificate of good conduct
- KRA Certificate of Tax compliance
- Clearance Certificate from HELB
- Copy of certificate of clearance from Credit
reference Bureau
