Quality Assurance Officer at Kenya Medical Research - KEMRI

Reporting to: Site Coordinator

JOB PURPOSE

The incumbent will be responsible for ensuring compliance with the clinical trial protocol; ensure site adheres to Good Documentation Practice (GDP); handling of the data and other materials at the site, including the Investigator Site File, completed CRFs, and the original medical records or files for each participant; internal quality checks in accordance with required study procedures and Good Clinical Practice (GCP) standards.

Essential Requirements:

1. Diploma /BSc. degree in Nursing and Clinical Officer.
2. Experience in clinical trials with at least two (2) year clinical work experience.
3. Have a good working knowledge of GCP requirements for clinical trials.
4. Attention to detail and systematic approach to their work.
5. Work with minimal supervision and have a high standard for research ethics

Duties and Responsibilities:

1. Monitor study team compliance with required study procedures as outlined in the protocol and GCP standards.
2. Review participant files for accuracy and ensure specific visit on CRF are completed as per GCP standards.
3. Assess and ensure site complies with GCP principles on study participant safety throughout participation in trial
4. Assist in monitoring, documenting and reporting adverse events to IRB and Sponsor
5. Maintain documents as required by regulatory agency guidelines
6. Resolve data queries and record discrepancies identified during in-house reviews
7. Report the problems requiring action to the clinical research coordinator and PI
8. Ensure that study ICFs are complete and obtained according to GCP standards and site SOP
9. Conduct staff training on quality assurance issues
10. Perform real-time quality control checks on Source documents and performing updates (if any)
11. Performs source data verification (SDV).
12. Supervision of maintenance of subject screening and enrollment logs
13. Writing and reviewing of study Standard Operating Procedures (SOPs)
14. Knowledge of protocol submission to IRB / Regulatory authorities is an added advantage
15. Perform other duties as assigned by the CRC, PI or clinical management team

Terms of employment

Employment is a one year renewable contract with a probation period for the first 3 months.

Salary is negotiable within the appropriate grade depending on education, experience and demonstrated competency.