REC Administrator

Background:

The Infectious Diseases Institute (IDI) is a Ugandan not-for-profit organization
whose mission is to strengthen health systems in Africa, with strong emphasis on
infectious diseases, through research and capacity development. IDI has six
operational areas through which it works to achieve its mission: Prevention, Care
and Treatment; Training, Research, Laboratory services (including the CAP-certified
IDI Core Lab & Translational Lab), Global Health Security and Health System
Strengthening.

IDI obtained accreditation from the Uganda National Council for Science and
Technology (UNCST) to host a Research Ethics Committee (REC) to contribute to
protecting of the human research participants’ rights, safety and welfare.
In order to successfully, implement the REC functions, IDI is looking for a competent
and experienced individual to fill the position below:

Job Title: REC Administrator

Vacancy Code: REC-001

Duty Station: Kampala

Classification: Full-time

Reports to: IDI-REC Chairperson

General summary:

The REC Administrator is instrumental in supporting the IDI-REC operations to meet
its primary responsibility of protecting the rights, safety and welfare of human research participants. The REC Administrator will serve as the IDI-REC interface for research participants, Investigators, Sponsors and regulatory agencies (i.e., UNCST and NDA). S/he will assist in planning and ensuring that pre-established work scope, study protocols, and regulatory/ethical requirements are followed.

Key Responsibilities:

A. Ensure that submitted research protocols are reviewed efficiently and consistently in line with national ethical regulations and guidelines by:

1. Having thorough knowledge of and ability to apply national regulations and guidelines and IDI-REC procedures.

2. Overseeing the accurate and timely processing, tracking, and filing of submissions to
and actions by the IDI-REC.

3. Effectively communicating with Investigators, Sponsors, REC Chairperson, and IDIREC members.

4. Obtaining and distributing information required for REC Chairperson or IDI-REC review, maintaining files, preparing and distributing minutes.

5. Assigning new protocols to IDI-REC members based on known or potential conflicts
as well as REC member expertise.

6. Compliance with submission requirements outlined in IDI-REC SOPs.

B. Maintain accurate records of IDI-REC actions by:

1. Recording meeting minutes in sufficient detail to document IDI-REC deliberations.

2. Documenting communications with Sponsors, Investigators, regulatory entities, and
any others involved in the conduct of submitted research.

3. Maintaining an accurate and comprehensive database of reviewed and approved
research.

4. Maintaining records of expedited reviews, risk determinations, and any other
activities that result in a review or action by IDI-REC staff or members.

5. Maintaining, filing and archiving systems that allow access to open and closed studies.

6. Reviewing and suggesting modifications in IDI-REC agendas and minutes.

7. Periodically reviewing IDI-REC policies and procedures to ensure appropriate
functioning of the IDI-REC.

8. Providing data entry to computer tracking system, generating letters, creating files and mailing notices to Investigators.

C. Ensure that Investigators and Sponsors are informed of the actions and findings of
the IDI-REC by:

1. Issuing notifications of IDI-REC actions to Investigators and other appropriate entities.

2. Reviewing IDI-REC SOPs on regular basis to ensure accurate information and disseminating changes to IDI-REC members.

3. Sending timely responses to written and phone messages requesting information.

4. Sending timely decision correspondence to appropriate parties.

D. Ensure that continuing review of approved research is conducted appropriately and in a timely manner by:

1. Making Investigators aware of due dates for submission of renewal and other reports.

2. Ensuring that information submitted by Investigators is adequate for effective review.

3. Reviewing procedures for obtaining continuing review information, adequacy of
information and need for additional information from sources other than the Investigator.

E. Serve as IDI-REC interface for participants, Investigators, Sponsors and regulatory agencies by:

1. Answering questions and supplying information when requested, and conveying IDIREC actions to appropriate individuals.

2. Screening participant inquiries and resolving issues when possible, and conveying results of interactions with participants to Investigators, Sponsors, and IDI-REC members as directed.

3. Serving as the IDI-REC liaison during audits by regulatory entities or Sponsors.

4. Scheduling IDI-REC meetings.

5. Conducting semi-annual assessment of IDI-REC office function and report writing.

F. Oversee adequacy of REC membership by:

1. Providing support to the REC Chairperson, IDI Institution Official, in the recruitment,
training, and continuing education of IDI-REC members.

2. Appraising the REC Chairperson of IDI-REC membership status and determining if
additional or new regular or alternate members are required.

3. Ensuring that a quorum is present and maintained during convened meetings.

4. Keeping REC members apprised of their responsibilities regarding conflicts of interest.

5. Reviewing IDI-REC minutes to ensure documentation of quorum for decisions
reported.

6. Working with REC Chairperson and others as required, to recruit and to supervise training of new IDI-REC members.

7. Maintaining IDI-REC membership logs and coordinating submissions to regulatory
agencies.

G. Track all IDI-REC income and expenses by:

1. Working closely with the designated Finance and Administration (F&A) Officer to invoice Investigators submitting research protocols/annual renewal requests to IDIREC for review.

2. Following up with F&A Officer to issue receipt for funds deposited by the Investigators prior to distributing the protocols/annual renewal packages for review by REC members.

3. Tracking all IDI-REC funds through the IDI cost recovery system and ensure that documentation of these funds is reflected in the financial reports.

4. Provide and maintain accountabilities for all IDI-REC related activities expenses including reports.

H. The REC Chairperson may delegate/assign additional duties and responsibilities
to the REC Administrator as needed.

Person specifications:

 Bachelor’s degree in a health-related field (preferably Biomedical Sciences).

 A certificate of Good Clinical Practice (GCP) and/or Human Subjects Protection
(HSP) is an added advantage.

 A certificate in project planning and management is an added advantage.

 Strong knowledge of national and international research ethical
guidelines/standards.

 At least two years working experience in a research regulatory and/or ethics
committee environment is highly desired.

 Good written and oral communication skills in English and the ability to
engage Investigators, Sponsors and IDI-REC members enthusiastically face-toface, telephonically, Zoom and via e-mail.

 Organizational skills and personal effectiveness skills are desirable.

How to apply;

Candidates that meet the above criteria and have what it takes to excel in these positions
should send their CVs, including details of email address, present position, current
remuneration, Certificate/testimonials and address of three (3) Referees plus telephone
contact to the stipulated email address not later than 21st February, 2021. Email your
application and CV to hr@idi.co.ug

Key Notes:

1. IDI is an equal opportunity employer and does not charge a recruitment fee or any other fees at any stage of the recruitment process.

2. Internal candidates who meet the required specifications and have worked with IDI for a period of at least one year will be given priority.

3. Make sure that your application letter, CV and certificates are attached as one document.

4. Indicate the Vacancy Code as the subject line of your email.

5. Please note that if you DO NOT indicate the vacancy code as instructed above, your
application will not be considered.

6. Any form of canvassing will lead to automatic disqualification.

7. Only shortlisted candidates will be contacted.

The Senior Human Resource Manager
Infectious Diseases Institute — IDI Knowledge Centre, Makerere University Main Campus
College of Health Sciences, Makerere University
P.O. Box 22418, Kampala, Uganda