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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
Interested candidates who meet the above criteria are encouraged to send in their applications through email; firstname.lastname@example.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.