Quality Assurance Officer (1 position) KMR 6 at Kenya Medical Research - KEMRI

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:

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

Duties and Responsibilities:

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