Quality Assurance Officers (2)

Job Title: Quality Assurance (QA) Officer (2) Location: Rachuonyo, Homabay County Reports To: Data manager / Study Coordinator / Principal Investigator Position Type: Full-time, Contract Job Purpose: He/she will be responsible for ensuring that the clinical trial is conducted in accordance with the protocol, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), sponsor requirements, and applicable regulatory guidelines.

The QA Officer will support quality systems at the site, conduct internal audits, review documentation, and assist with inspection readiness.

Key Responsibilities: Oversee the implementation and maintenance of quality systems to ensure trial compliance.

Review study documentation (e.g., source documents, case report forms, logs) for accuracy, completeness, and compliance.

Ensure timely resolution of deviations, non-conformances, and queries.

Conduct regular internal QA audits of clinical, laboratory, pharmacy, and data areas.

Prepare audit reports, identify gaps, and follow up on corrective and preventive actions (CAPA). Support external monitoring visits, sponsor audits, and regulatory inspections.

Maintain and ensure use of current versions of study protocols, SOPs, logs, and guidelines.

Ensure documentation of training and SOP compliance across all study team members.

Track and archive essential study documents in the Trial Master File (TMF) or Investigator Site File (ISF). Coordinate and/or facilitate GCP, protocol, and QA-related training for study staff.

Ensure continuous quality improvement through capacity building and feedback mechanisms.

Maintain an audit-ready site at all times through regular QC checks and support for all departments.

Prepare for sponsor, IRB/EC, and regulatory authority inspections in collaboration with the site team.

Qualifications & Experience: Bachelor’s degree in health sciences, clinical research, pharmacy, public health, or a related field.

Certification or training in GCP, QA, or clinical research monitoring is strongly preferred.

Minimum of 2–3 years of experience in clinical research, preferably in quality assurance or monitoring.

Familiarity with ICH-GCP, local regulatory requirements, and clinical trial procedures.

Key Competencies: Strong knowledge of QA principles and clinical trial processes.

High attention to detail and accuracy.

Excellent analytical, organizational, and communication skills.

Ability to work independently and as part of a multidisciplinary team.

Proficient in Microsoft Office and clinical documentation systems.

Working Conditions: Office-based with frequent interaction across clinical, data, pharmacy, and lab departments.

May include occasional travel to other sites or attendance at QA-related meetings and trainings.

May require flexible working hours to meet audit and reporting timelines Applications must include the following: Application letter, Complete CV with 2 referees indicating their telephone contacts and e-mail contacts Relevant certificates and testimonials If qualified for the above post, please send your application addressed to the Principal Investigator, MK8527 Study.

If qualified for the above post, please send the above documents to the email by 27/7/2025 NB: Applications without the above-mentioned qualifications or required certificates will NOT be considered.

Only shortlisted candidates will be contacted.

Click on the link below and fill out the Google form.