Assistant Research II, Quality assurance officer
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Job description
Transfer Vacancy (similar position of equal grade and salary) Organization: Armauer Hansen Research Institute (AHRI) Position : Assistant Research II, Quality assurance officer Department: Clinical Trial Directorate Employment term : Permanent No. Required : One (1) Grade : XIV Salary : 19,464.00 (Nineteen thousand four hundred sixty four birr) Home Allowance : 2,500.00 (Two thousand five hundred birr) Mobile & Internet Allowance : 500.00 (five hundred) Background: Clinical Trial Quality Assurance Officers ensure that studies are conducted in compliance with Good Clinical Practice (GCP), regulatory requirements, and approved protocols. They oversee quality systems, conduct audits, manage CAPAs, and promote continuous improvement to ensure data integrity and participant safety. Key Responsibilities • Ensure Compliance with Standards • Ensure all clinical trials comply with Good Clinical Practice (GCP), study protocols, and regulatory requirements • Monitor adherence to institutional SOPs and ethical guidelines • Plan and perform internal audits (site, system, and process audits) • Prepare sites for sponsor and regulatory inspections • Review deviations, non-compliance, and audit findings • Ensure appropriate root cause analysis is conducted • Track implementation and effectiveness of CAPAs • Review, approve, and maintain Standard Operating Procedures (SOPs) • Ensure proper version control and document archiving • Support development of new SOPs when needed • Ensure staff are trained in GCP, SOPs, and protocol requirements • Verify proper documentation of informed consent and source data • Ensure data integrity and traceability • Ensure compliance with national regulatory authorities (e.g., EFDA) and ethics committees • Support submissions, reporting, and inspection readiness • Analyse trends in deviations and audit findings