Opening Date: 11thNovemebr, 2020 Closing Date: 30th November, 2020 Background Information:
The Kenya Medical Research Institute (KEMRI), in collaboration with the University of California, San Francisco through an NIH funded grant is setting up a new Study, SEARCH-SAPPHIRE trial, aimed at piloting HIV treatment and prevention interventions with the goal of further reducing HIV incidence following the successes recorded in the SEARCH trial. The study will be conducted in Homabay and Migori counties and has the following vacancies to be filled.
3. Position: Regulatory Coordinator (1 Position) KMR/6 Vacancy No. FN-004-11-2020
Reports to: Study Coordinator
Duration: 7 Months
• 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
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
Interested candidates who meet the above criteria are encouraged to send in their applications through email; email@example.com
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.