Research Administrator (Regulatory) at Kenya Medical Research - KEMRI

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:

1. Bachelor of Science Degree nursing, social sciences or a health-related discipline
2. Experience in Regulatory Affairs/Quality Assurance
3. Training on Regulatory Affairs/Quality Assurance/Clinical trials will be an added advantage
4. Fluency in Kiswahili and English – both written and oral
5. Training in Good Clinical Practice (GCP) and other applicable regulations.

Skills and abilities:

1. Excellent interpersonal and organizational skills
2. Attention to details,
3. Ability to work with minimal supervision

Position Descriptive:
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.

Specific tasks and responsibilities:

1. Maintain studies’ compliance with applicable guidelines and regulations as well as all relevant local laws. at all times.
2. 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.
3. Maintain documents as required by regulatory agency guidelines.
4. Organize, coordinate, and document all training undertaken in respect to the study and to file all the relevant training records.
5. Conduct periodic internal monitoring and audits of studies within FHU to ensure compliance with the protocol, SOPs, GCP and all the applicable regulations.
6. Assist in conducting periodic internal monitoring activities for studies within FHU
7. Tracking, documenting, and reporting adverse events
8. Training of staff on quality assurance issues.
9. Writing and reviewing of Standard Operating Procedures.
10. Developing of study source documents.
11. Any other duties assigned by the immediate supervisor.

Terms of Employment:

1. Terms of Employment: One (1) year renewable contract as per KEMRI scheme of service and a probation period for the first 3 months.
2. Remuneration: Compensation is as per the stated salary scale, which is based on academic level, relevant experience and demonstrated competency.