The Armauer Hansen Research Institute (AHRI) was founded in 1970 through the initiative of
the Norwegian and Swedish Save the Children organizations seconded by the Ministry of Health
of Ethiopia. The Institute got its name from the Norwegian physician, Gerhard Henrik Armauer
Hansen, who first described the leprosy bacillus (Mycobacterium leprae). AHRI is a biomedical,
Clinical trial, Vaccine and Traditional Medicine research institute that works in developing tools
for clinical trial, Vaccine, prevention, control and treatment of neglected tropical disease (NTD)
and other diseases of public healthy importance through applied, basic biomedical research,
clinical trial and training.
Applied knowledge and skill
This is a Clinical Trail Quality Assurance Officer (CTQAO) is a specialized research
professional working with and under the direction of both the clinical trial Principal Investigator
(PI) and Study coordinator (SC). While the Principal Investigator or study coordinator is
primarily responsible for the overall design, conduct, and management of the clinical trial, the
CTQAO supports, facilitates and coordinates the daily clinical trial activities and plays a critical
role in the conduct of the study. By performing these duties, the CTQAO closely works with the
PI, SC, department, sponsor, and institution to support and provide guidance on the
administration of the compliance, personnel and other related aspects of the clinical trial study.
The clinical trial Quality Assurance reports primarily to the clinical trial Directorate with
associated responsibilities to the department head, Data manager or program administrator
Major role and responsibility
Assuring compliance with Ethiopia Food and drug Authority (EFDA) and Good Clinical
Practices (GCP) regulatory requirements.
Provide Good Laboratory Practice (GLP) and Good Manufacturing practice (GMP)
compliance support.
Provide training and guidance in the areas of government regulations to clinical project
teams
Provide CQA oversight of clinical trial-related activities
Review regulated documents, such as SOPs, Trial Master Files, Informed Consents,
protocols and final reports
Conduct audits of internal and external partners to assess compliance with GCP
requirements for clinical trial-related activities
Audit study reports and raw data for compliance with protocols, SOPs and regulations
Lead interactions with AHRI clinical trial and development personnel regarding clinical
compliance matters
Communicate compliance requirements at all levels
Identify compliance weaknesses and assist with the implementation of workable solutions
Provide risk assessment expertise for internal projects and processes.
Conduct internal audit as per the protocol stated Perform other related duties as required