KEMRI / UW Research Collaboration Regulatory Affairs Officer Job in Nairobi, Kenya - Kenyan Jobs Blogspot :: A Collection of Jobs in Kenya

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Dec 13, 2017

KEMRI / UW Research Collaboration Regulatory Affairs Officer Job in Nairobi, Kenya

The KEMRI / University of Washington Study

The KEMRI / UW research collaboration aims to conduct interdisciplinary, setting-specific research aimed at improving the lives of women and children living in Kenya.

Specifically our research strives to understand various infectious diseases afflicting these populations and testing interventions. 

We are looking for motivated, committed, and honest staff members to join our team.

Job Title: Regulatory Affairs Officer

 
Job Ref: MR/7 

1 Position

Location:
KEMRI / UW Nairobi Office.

Report to: Research Manager/Principal Investigator

Job Description: Regulatory affairs officer will act as a link between KEMRI-UW research team and regulatory authorities (SERU/PPB/UW-IRB etc.), ensuring that research protocols are implemented in compliance with appropriate ethical regulations and relevant legislations. 

Reporting to the research manager/principal investigator, the officer will provide regulatory support services to research in the planning and conduct of clinical trials and other studies, including development of applications and in interactions with the local regulatory bodies supporting the filing and ongoing management of  applications.
 
Job Responsibilities:
  • Assist investigators and research teams with determinations of applicability of regulatory requirements, including conducting the necessary regulatory and scientific literature searches.
  • Provide guidance to investigators on the use of institutional templates for relevant applications.
  • Serve as an educator and lead individualized/group training sessions to ensure regulatory compliance with regulatory requirements, and institutional policies and SOPs.
  • Maintain up-to-date knowledge on local and international partner regulatory requirements and current practice standards for clinical trials including regulatory submissions.
  • Train and provide regulatory guidance to project teams and staff.
  • Contribute significantly to the development, implementation and ongoing evaluation of strategies and processes to improve and ensure that research at the KEMRI-UW is conducted in accordance with all required regulations
  • Direct and oversee short-term and long-term planning of regulatory submission initiatives.
  • Manage regulatory submissions and provide guidance to study coordinators on preparation of relevant reports and documents.
  • Prepare responses to inquiries from regulatory authorities.
  • Prepare/review and submit applications and reports to regulatory bodies including but not limited to new applications, continuing review reports, amendments, protocol violations/deviations, SAE reports etc.
  • Monitor and update national and international registration requirements as appropriate.
  • Coordinate and prepare document packages for regulatory submissions ensuring compliance with all regulatory requirements.
  • Liaise with internal and external bodies (including research partners such as hospital and other KEMRI Centers) and ensure that accurate documents are obtained from and given to these organizations in order to maintain regulatory approval.
  • Assist with other duties as directed by the Research Manager/Principal Investigator
Required Qualifications:
  • Diploma in Social Sciences or related courses
  • Holds a current practicing license, if applicable.
  • Three years of working experience as a Regulatory officer or related duties
  • Demonstrated competency in handling of research regulatory matters
  • Computer literate
  • Strong interpersonal, communication, and listening skills
  • Must be able to work in a professional and ethical manner with competence, accountability, and integrity
  • Basic computer skills
  • Detail-oriented
  • Good negotiation and problem solving skills
  • Excellent Time management skills
 Effort: 100%

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 negotiable within a relevant grade, based on educational levels, relevant experience and demonstrated competency. 

The salary scheme is based on the KEMRI salary scales.

If you meet the above requirements, please click on the link below to complete the application form:
https://docs.google.com/forms/d/1OcWNdgw3tcrdSV58FPlIAxaSuGULlO5PjQkFqHEO3II/edit
and then send an application with your current CV that contains details of your qualifications, experience and the full time telephone number and names and addresses of 3 referees to Email address: [email protected] to reach us by 21st December, 2017 at 4.00 p.m.
 
KEMRI IS AN EQUAL OPPORTUNITY EMPLOYER COMMITTED TO DIVERSITY; PERSONS WITH DISABILITY, WOMEN, YOUTH AND THOSE FROM MARGINALIZED AREAS ARE ENCOURAGED TO APPLY.

KEMRI DOES NOT CHARGE A FEE AT ANY STAGE OF ITS RECRUITMENT PROCESS INCLUDING APPLICATION, INTERVIEW AND PROCESSING OF OFFER LETTER. IF ASKED FOR A FEE, REPORT SUCH REQUEST IMMEDIATELY

Note: Only the shortlisted candidates will be contacted.


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