Background

The Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa) is a World Bank supported African center of excellence for education and research at the College of Health Sciences of Addis Ababa University (CHS AAU). The main aim of CDT-Africa is to serve as a platform for equitable access to medicines (drugs, vaccines and diagnostics) and bring about sustainable development in Africa through high-quality capacity development for innovative medical discovery.

As part of its mandate to strengthen clinical trials and regulatory affairs, the Center would like to employ one Institutional Review Board (IRB) Secretariat Officer to support the regulatory affairs works of CDT-Africa under the IRB of the CHS AAU. The IRB of the CHS AAU is one of only three IRBs in Ethiopia that received Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) recognition from World Health Organization. To enhance the IRB’s functions and efficiency, a qualified secretariat officer having the required training and experience is required.

Job Summary

The IRB Secretariat Officer will support the IRB of the CHS AAU by ensuring a good and timely implementation of IRB activities including but not limited to: (a) managing the IRB office activities, (b) archiving documents, (c) coordinating IRB meetings, and (d) communicating with IRB stakeholders under the supervision of the IRB chairperson. The Officer is also responsible for supporting the Regulatory Affairs Lead of CDT-Africa.

Duties and Responsibilities

The main duties and responsibilities of the IRB Secretariat Officer will be:

• Informing and advising the principal investigators, sponsors, and new IRB members of applicable regulations, guidelines, processes and procedures;
• Managing the timely progress of protocol review through initial and continuing contacts with Principal Investigators. This includes identifying and requesting missing documentation in applications and preparing the completed file for review;
• Preparing the meetings of the IRB, including the distribution of relevant documentation to the members, scheduling the meetings, and ensuring the quorum;
• In close collaboration with the chairperson of the IRB, preparing applications that will be evaluated through expedited review;
• Following-up with tasks that the IRB requests the principal investigators to perform such as progress reports, final reports, corrective actions, amendment of the approved protocol or consent documents etc;
• In close collaboration with the secretary of the IRB, preparing minutes of IRB meetings;
• In close collaboration with the chairperson of the IRB, preparing reports of IRB meetings and annual reports of IRB activities. The annual report includes information about sources of funding and expenses of the IRB;
• In close collaboration with the chairperson and members of the IRB, seeking grants to support the activities of the IRB;
• Record keeping, including maintaining research protocols and all correspondence in relation to their review, as well as records of any continuing oversight that may be required after approval. The Officer ensures that the confidentiality of IRB records is maintained;
• Facilitating access to literature and educational programs useful to the members of IRB;
• Updating information about IRB membership, including declarations of potential conflicts of interests;
• Supporting the regulatory affairs work of the CDT-Africa under the guidance of the Regulatory Affairs Lead of the Center; and
• Performing other duties as assigned by the immediate supervisor or the IRB Chairperson, as appropriate in light of the IRB Officer’s training, expertise, capacity, and resources. Such responsibilities may include keeping abreast of developments in research ethics and regulation, engaging in trainings and community outreach, serving as a liaison between the IRB and the research community, and facilitating implementation of quality improvement and quality assurance programs.

Terms and conditions

• Salary: Negotiable depending on qualifications and experience.
• Hours of Work: Are governed by the laws of Ethiopia. However, the nature of the work is such that it might require working overtime and weekends.
• Holidays: Are governed by the rules of Addis Ababa University for project workers.
• Length of Contract: This is a four years post subject to annual contract renewals.
• Probationary Period and Notice Period: There is a three-month probationary period for this role.

Accountability and expected outcome

• The IRB Secretariat Officer is responsible for reporting on activities to the chairperson of the IRB and the Research and Technology Transfer Director of CHS AAU for IRB related tasks, and to the Regulatory Affairs Lead of CDT-Africa for the Center’s specific activities.
• The IRB Secretariat Officer will improve the performance and timely delivery of IRB tasks and projects in particular in the fields of communication and administrative management.

Terms and conditions:

• Hours of Work: Are governed by the laws of Ethiopia. However, the nature of the work is such that it might require working overtime and weekends.

No required: One

• Planning: Ability to identify priority activities and assignments, allocation of appropriate amount of time and resources for completing given tasks;
• Communication: Excellent communication skills in English;
• Experience in using communication tools: Good computer skills;
• Curiosity and open-mindedness: ability to ask questions to clarify, exhibit interest in having two-way communication, and demonstrate openness in sharing information and keeping people informed;
• Teamwork: ability to work collaboratively with IRB stakeholders to achieve IRB goals, willingness to learn from others, ability to work in a multi-cultural environment, capacity to work with transparency, and capacity to build trust in colleagues.

Qualification

• Education: Master’s degree in health sciences or related fields;
• Professional Experience: At least 1 year work experience after masters. It is an advantage that the candidate has prior experience related to Research Ethics
• Languages: Fluency in written and spoken English is essential; ability to work in other Ethiopian languages is an asset.

Other Skills

• Able to foster cooperation among research team and relevant stakeholders;
• Excellent command of communications programs and software (graphic design, etc);
• Excellent computer skills are required in the complete Microsoft Office Suite (Word, Excel, PowerPoint, Project, Publisher, and Access).

Application should be submitted within 10 days of this job announcement. Please note that only shortlisted candidates will be contacted.