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
