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Position Title: Member, Expert Committee On Clinical Trials (ECCT)

Number Of Posts: Six (6)

Terms Of Service: On Ad Hoc Basis When Need Arises

Duration Of Service: Three Years Renewable Term

Reporting To: Registrar

JOB DESCRIPTION

The Pharmacy and Poisons Board is the National Drug Regulatory Authority for Kenya and part of its mandate is the regulation of clinical trials taking place in the country. This it does by among other things; reviewing and approving clinical trials applications, review and approval of amendments to the protocols, carrying out Inspections at clinical trials sites, reviewing the clinical final study reports.

Pharmacy and Poisons Board at times uses expert committees to carry out its mandate and would like to increase the current membership of the clinical trials committee. The committee works to facilitate the carrying out of clinical trials in Kenya but also ensuring the safety, well-being and integrity of data generated in clinical trials with more focus on the investigational products.

DUTIES AND RESPONSIBILITIES

  • Review of clinical trials protocols with focus on the investigational products
  • Review of proposed amendments to approved protocols
  • Participate in clinical trial site inspections
  • Participate in joint reviews of clinical trials applications taking place across the East African Community
  • Monitoring of approved clinical trials
  • Participate in the development of guidelines and legislation on the regulation of clinical trials in Kenya
  • Advice the Registrar on matters pertaining to regulation of clinical trials in Kenya
  • Participate in the Expert Safety Review Panel so as to monitor the safety of the pharmaceutical products in Kenya.
  • Participate in the development/upgrading of the Kenya Clinical Trials Registry

REQUIRED QUALIFICATIONS

For appointment to this position, a candidate must have; -

  1. A Bachelor Degree in Pharmacy, Medicine or any Health Related field from a recognized university
  2. At least 5 years relevant clinical trials experience in his/her field of expertise.
  3. Excellent Proficiency in Microsoft Office Suite, especially MS Word, MS Excel, MS PowerPoint and internet
  4. Meet the requirements of Chapter 6 of the Constitution of Kenya.
  5. In addition, the applicant should have PhD in any of the following areas
    • Drug Development
    • Preclinical Trials
    • Genetics/ Biotechnology
    • Biostatics/Medical Statistics
    • Non-Communicable diseases
    • Vaccinology/ Immunology
    • Medical devices

 

The candidates should submit six copies of the following documents:

  1. Detailed Curriculum Vitae
  2. Copy of National identity Card
  3. Academic and professional certificates,
  4. Clearance certificate from the following bodies:
  • Kenya Revenue Authority
  • Criminal Investigations Department
  • Relevant Professional association

The application should be sent in a plain and sealed envelope clearly marked “Application for Expert Committee on Clinical Trials (ECCT)” and deposited or sent to the Pharmacy and Poisons Board through the following addresses.

Registrar,

Pharmacy and Poisons Board

PPB House Hurlingham,

Lenana Road

P.O Box 27663-00506

Nairobi

The closing date is on Friday 21st October 2016 at 4.00pm

Only shortlisted candidates will be contacted. The Board is an equal opportunity employer