Women’s Health Project
Clinical Trial Coordinator
The Women’s Health Project,
established in 1993, is a collaborative effort of the University of Nairobi
(UoN), the University of Washington (UW), the Kenya Medical Research Institute
(KEMRI), Mombasa County and the Fred Hutchinson Cancer Research Center (FHCRC),
and the US President’s Emergency Program for AIDS Relief (PEPFAR).
To provide high quality care to at-risk and HIV-positive
women participating in the high-risk women’s cohort (Mombasa Cohort).
To conduct innovative prevention and treatment research that
will contribute substantially to local as well as global knowledge and
implementation of effective interventions.
To conduct clinical trials according to ICH-GCP/FDA/local
regulatory guidelines and deliver quality services, products and devices.
Position: Clinical Trial Coordinator
Supervisor: Clinic Section Head
Employment Type: One-year renewable contract (probation period
for the first 3 months)
Opening Date: 15th November 2023
Closing Date: 5:00 PM on 6th December 2023
Job Summary: The clinical trial coordinator will work under the
mentorship of the clinical research investigator and senior staff within the
site to manage daily activities of assigned clinical research studies.
Essential Job Functions:
Conduct participant study visits and clinical assessments,
document study procedures, and interpret laboratory findings in
collaboration with the study PIs.
Develop a comprehensive understanding of study protocols,
objectives and logistics essential for carrying out research studies and
Maintain daily oversight of study implementation.
Coordinate the study team to ensure proper performance of
study and project activities in accordance with ICH-GCP/FDA and local
regulatory and ethics requirements.
Ensure proper training, documentation and delegation of
functions for the relevant research personnel.
Work closely with regulatory officers in tracking and
updating various submissions.
Coordinate the collation of study documents for submission to
IRBs and RAs.
Develop site specific addendums, Informed Consent Forms
(ICFs), Case Report Forms (CRFs) and posters/flyers.
Ensure participant privacy and confidentiality are maintained
at all times.
Ensure informed consents are obtained for all participants
prior to study participation.
Document and report any breach in compliance through
corrective and preventive actions (CAPAs), protocol deviations, note to
files, memos etc.
Documenting and reporting of safety reports to IRBs and RAs
in a timely manner.
Maintaining the Investigator Site File (ISF).
Maintaining the enrolment, consenting and re-consenting logs.
Communication with study sponsors or their representatives
(Monitors, Auditors, Vendors etc.)
Develop Standard Operating Procedures (SOPs).
Performing Quality Assurance (QA)Quality Control (QC)
Data entry where applicable.
Query follow up and resolution.
Drafting study needs such as files, cabinets, medical
equipment etc. for purchase.
Work professionally and ethically with competence,
accountability, and integrity.
Perform any other relevant duties as assigned by the
Qualifications / Skills / Experience
Bachelor of Medicine and Bachelor of Surgery (MBChB) with at
least 1-year experience in leading clinical trials.
Bachelor’s Degree/Higher Diploma/Diploma in Clinical Medicine
or Nursing with at least 2 years’ experience leading a clinical trial.
Duly registered by the relevant professional body.
Hold a valid practicing license.
Excellent interpersonal skills and a willingness to work with
others to overcome problems as and when they arise.
Effective oral and written communication skills, including
project reporting, including using MS Word, Power point, and MS Excel.
Strong organization skills and attention to detail.
How to Apply
Applicants who meet the
specified requirements should send the following documents to
Detailed CV with 3 referees.
Copies of academic and professional certificates.
Current practicing license if applicable
Subject should read “Clinical
Only shortlisted candidates
will be contacted