Uganda-Cwru Research Collaboration Invites Applications From Suitably Qualified Professionals To Fill The Position Of Regulatory Affairs Coordinator

The Uganda-CWRU Research Collaboration (UCRC) is a research collaboration in Uganda between Makerere University and Case Western Reserve University in Cleveland Ohio, USA with a primary focus on research to improve infectious disease management, primarily tuberculosis and related diseases.
The Collaboration now seeks to hire a full time Regulatory Affairs Coordinator on a yearly contract with potential options for renewal depending on performance and availability of funds.

Position objective
• Provide support for the human subject regulatory approval processes for various epidemiologic, clinical trials, interventional and laboratory research studies for the UCRC.
• Draft, track and ensure follow-up of regulatory correspondence, including general submissions, adverse event reporting, protocol deviations, annual reports and continuing renewal to appropriate ethics committees/IRBs; maintain and prepare onsite regulatory files for monitoring visits;
• Plan and organize staff training for compliance with the local and international Good Clinical Practice and Human Subject Protection regulations.
• Coordinate all efforts with US-based personnel and/or other sponsor personnel to ensure regulatory requirements are met within required timelines.
• All members of the Collaboration are required to work as a team to promote a professional work environment.

• Employment Requirements
• Bachelor’s Degree in a health science or related field. Clinical training preferred but previous work experience in clinical research will be considered
• Excellent verbal and writing communication skills; and able to work with national and multinational team members. Ability to read and communicate in local languages around Kampala, Mukono and Wakiso areas.
• Excellent organization skills, including in planning, hard copy and soft copy documentation
• Strong interpersonal skills and be able to communicate research regulations to individuals of various educational and cultural backgrounds.
• Excellent problem solving skills, detail oriented, and ability to work well independently.
• Able to use Microsoft Office products (Word, Access, Excel, and Power Point) with additional data management/entry systems an added advantage
• Preferably three years’ experience working in clinical research, preferably with experience working with local ethics committees
• GCP and HSP trained with a familiarity in U.S. (45 CFR) and international ICH regulations.

Essential Functions
• Manage and coordinate research regulatory activities, working with both Ugandan and U.S. based researchers and regulatory staff
• Drafting, coordinating and submitting initial regulatory approval, continuing
• reviews, and protocol amendments to the responsible ethics committees; coordinating all submissions with the designated CWRU or other sponsor Regulatory Coordinator and Principal Investigator(s) in a timely manner.
• Draft cover letters, responses to regulatory comments, and additional communications to the ethics committees to facilitate reviews and address committee concerns.
• Assist with review/drafting of study consent forms including coordination and confirmation of final translation and back translation of consent forms as required by the sponsor.
• Serve as liaison between Principal Investigator(s). site monitors, CWRU/other sponsor regulatory personnel, and Study Coordinators on regulatory issues; ensure project regulatory status is up to date and regulatory concerns are addressed in a timely fashion, including preparations for site audits.
• Maintain and coordinate with CWRU or other sponsors, central regulatory study files for all studies, including current copies of study protocols, ethical review documentation, key correspondence, Curriculum vitae, signature lists, and all other sponsor required documentation for both investigational new drug (IND) and non-IND/observational studies.
• Assist with new staff orientation in scheduling required regulatory training (GCP, HSP).
• Ensure training documentation is tracked and maintained for all personnel and provided to the CWRU Coordinating Center or other sponsors as indicated.
• Audits and tracks all completed study consents for enrolled participants and confirms correct versions are utilized for each study, follows-up timely on consent errors and omissions.
• Ensures proper submission and reporting of Serious Adverse Events to appropriate ethics committees, CWRU, sponsor, and maintaining documentation in the central study file.
• Ensure proper submission and reporting of study protocol deviations to appropriate ethics committees, CWRU, sponsor, and, maintaining documentation in the central study file.
• Maintains updated investigator cards annually
• Conducts and records audits of regulatory files per the current Quality Management Plan or other sponsor requirements.
• Provides additional support as part of the data management team, including data abstraction, entry, review of records, and additional activities as may be identified.

Method of Application

Applications with recent CV, letters from 2 relevant referees with telephone contacts, ONLY “O” and “A” level pass slips or certificates, tertiary transcripts and University certificates should be sent to:
Administrative Manager,
Uganda-CWRU Research Collaboration,
P. O. Box 663 Kampala,
Phone:+256-786-663184/+256-753-630829;
Email: [email protected] .
Closing Date: 2nd July, 2021 Only short listed candidates will be contacted for interviews.