CRA Site Observational Attachment Job Vacancy in Kenya

The Women’s Health Project

Position Title: CRA Site Observational Attachment

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: CRA Site Observational Attachment (2 positions)

Supervisor: Clinic Section Head

Job Summary: Work collaboratively with the study teams with the review, revision and writing of protocols, Case Report Forms (CRF) and other required documents for clinical research studies initiation, conduct, monitoring, auditing, inspection and closeout.

At the end of the internship you should be competent to:

  • Write, review, revise and translate Informed Consent Forms (ICF).
  • Assess patient recruitment and retention success.
  • Support the daily operations of clinical research studies to ensure timely start-up, accrual, maintenance and close-out of assigned studies.
  • Verify and review shipping procedures, accountability, inventory and storage of the I.P
  • Assist with the training and supervision of newly hired Clinical Research Associates (CRAs)
  • Review the Trial Master File (TMF) documents.
  • Ensure that all regulatory requirements are met for all studies
  • Ensure the clinical trial is being performed according to ICH/GCP guidelines and meeting the protocol requirements.
  • Plan, coordinate and facilitate investigator meetings.
  • Plan, coordinate and facilitate audit/inspection meetings.
  • Communicate with study centers, addressing issues and disseminating study related materials when needed.
  • Train investigators and site personnel on documentation and reporting of adverse events including SAEs, SUSARs etc.
  • Perform Source Data Verification
  • Build competence in EDC and query resolution
  • Develop Quality Management Plans
  • Develop Monitoring SOPs
  • Competent in understanding various local IRBs and RAs processes (KNH-UoN, KEMRI-SERU) PPB, NACOSTI, KENTRADE, MOH etc.
  • Understand and participate in drafting MTAs among other Agreements.
  • Demonstrate leadership in managing a site as a monitor.

Education & Qualifications

  • Bachelor's Degree/Higher Diploma/Diploma Nursing, Pharmacy, Medicine, Biological Sciences, Life Sciences and Allied Health Sciences.
  • Licensing or Certifications.
  • GCP, HSP, CRA Certification.

Skills & Competencies:

  • Problem solving - Problem solving skills.
  • Organization - Planning, time management and prioritization skills.
  • Prioritization - Ability to handle conflicting priorities.
  • Quality - Attention to detail and accuracy in work.
  • Results-oriented approach to work delivery and output.
  • Leadership - Good influencing and negotiation skills.
  • Good judgment and decision-making skills.
  • Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.
  • IT skills - Good software and computer skills, including Microsoft Office applications.
  • Collaboration - Ability to establish and maintain effective working relationships with coworkers.
  • Effective communication - Ability to influence without authority.

How to Apply

Applicants who meet the specified requirements should send the following documents to

  • Application letter.
  • Detailed CV with 3 referees.
  • Copies of academic and professional certificates. (CRA Certification MUST be included)
  • Current practicing license if applicable

Subject should read “CRA site observational attachment”

Closing Date: 5.00PM on 15-Sep-2023

Only shortlisted candidates will be contacted