KEMRI – Regulatory Coordinator.

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KMR/6 Vacancy No. FN-004-11-2020
Reports to: Study Coordinator
Locations: Suba/Rongo
Duration: 7 Months

Qualifications:

  • Bachelor’s degree in Health or social sciences from a recognized university. A relevant master’s degree is preferred
  • Additional training in a management related field and research ethics is an added advantage
  • Proven experience working on ethical/regulatory submissions to applicable IRBs

Duties and responsibilities:

The Regulatory Coordinator is immediately responsible for all aspect of the ensuring regulatory compliance of the study intervention. Specifically, the Regulatory coordinator is responsible for:

  • Leading development and maintenance of Study Master File/Investigator Site Files
  • Preparing the sites for external study monitoring visits and writing post visit reports
  • Acts for and on behalf of the study manager with regards to regulatory compliance
  • Works together with the study coordinators/HoDs in ensuring timely submissions to KEMRI SERU/PPB
  • Oversee maintenance of Trial Master File and/or Investigator Site File (ISF)
  • Maintaining up to date regulatory binders for the study including the Study Master File (SMF) essential documents, delegation of duties log, training files, etc
  • Planning and conducting internal site monitoring for the study and following up on proposed action plans
  • Working with external monitors during monitoring visits and spearheading resolution of monitoring visit clarification forms
  • Coordinating and documentation of study related internal trainings/curricular
  • Active role in review process for study SOPs
  • Checking and ensuring regulatory compliance by all departments of the study
  • Working with the Clinic team on Protocol deviations/violations and SAE/UAE reporting especially with regards to maintenance of logs and filing of reports
  • Working with respective departments on implementation of the Study Quality Management Plan
  • Other duties as delegated by the Study Manager/PI
  • In the absence of the Regulatory Coordinator, one of the regulatory officers assumes the responsibilities of the coordinator in consultation with the study manager and other HoDs.

Other require skills

  • Comfortable with paperwork with a strong bias towards GCP/GCLP reviews
  • Excellent record keeping and filing skills
  • Exceptional reporting and report writing skills in relation to research studies
  • Ability to multitask, problem solve, and work with others to resolve challenges.
  • Strong communication, training/teaching, leadership skills
  • Excellent organizational skills and demonstrated competence with managing administrative records.
  • Excellent interpersonal and communication skills; able to communicate effectively both orally and in writing
  • Ability to monitor, gather and evaluate information of broad scope and complexity

Interested candidates who meet the above criteria are encouraged to send in their applications through email; hrrctp@kemri-ucsf.org

Applications should include the following:

  • A cover letter stating current position and date available to start working for the program
  • A current CV including email and mobile phone contact
  • Name and phone number for two professional referees
  • Two letters of recommendation
  • A copy of the latest pay slip (if applicable)
  • Copies of academic and professional certificates

KEMRI IS AN EQUAL OPPORTUNITY EMPLOYER COMMITED 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 SELECTION PROCESS INCLUDING APPLICATION, INTERVIEW AND PROCESSING OF OFFER LETTER. IF ASKED FOR A FEE, REPORT SUCH REQUEST IMMEDIATELY.

Only shortlisted candidates will be contacted.

https://www.kemri.org/careers/

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Kenya Medical Research Institute (KEMRI)

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