Job Title: Regulatory Officer – MUWRP Jobs 2022
Organization: Makerere University Walter Reed Project (MUWRP)
Duty Station: Kampala, Uganda
Position Number: MUWRP/01/06/22
Makerere University Walter Reed Project Profile:
Makerere University Walter Reed Project (MUWRP) is a non-profit biomedical research Organization, whose mission is to mitigate disease threats through quality research, health care and disease surveillance. MUWRP was established in 2002 by a Memorandum of Agreement between The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and Makerere University (Mak) to undertake medical research to test HIV vaccines. Over the years, MUWRP’s portfolio has progressively expanded to include vaccine research for Ebola and Marburg viruses, surveillance of influenza and influenza- like viruses and other emerging infections in humans and animals; also epidemiological, basic and implementation research in HIV treatment, care and prevention programs in the Districts of Kayunga, Mukono, Buvuma and Buikwe.
Job Summary:
The candidate will serve as Regulatory Officer for the Makerere University Walter Reed Project and will provide assistance to the CQI & Compliance Coordinator and liaise with investigators and other research staff to ensure compliance with local and international regulatory and ethical guidelines/ regulations for research conducted at MUWRP.
Roles and responsibilities:
- Prepare various ethical and regulatory submissions including initial submissions, continuing review reports, SAEs, protocol deviations, close out reports and any communication with the local IRB and sponsors.
- Liaising with ethical or regulatory body (in collaboration with the PIs) as well as initiating and maintaining pertinent correspondences.
- Tracking expiration of various protocol approvals at multiple ethical and regulatory bodies, drafting respective annual progress reports with timely submission as per institutional SOP.
- Maintaining all essential and other regulatory documents accurately and efficiently.
- Maintaining protocol-specific source documents and CRFs, as well accurate log(s) of these.
- Developing SOPs and source documents as may be required and ensuring clinic staff are annually trained on applicable SOPs.
- Version control and tracking of all site-specific source documents and CRFs and ensuring only current IRB approved versions of protocols and informed consents (including applicable translations) are in use.
- Identification and/ or documentation of non-compliance to protocols for corrective action, along with pre-emptive steps taken.
- Maintaining and tracking of research-staff CVs, GCP, HSP, SOP and protocol-specific trainings; and applicable practicing licenses as per local, international and sponsor requirements/ regulation.
- Coordinate Site Monitoring Visits
Other General roles:
- Understanding and adhering to MUWRP compliance standards as they appear in the HR policy manual, Code of Conduct, and Conflict of Interest Policy.
- Keeping abreast of pertinent international and local, clinical research guidance,
regulations, and policies as they presently exist and as they are modified. - Other duties as may be delegated by the CQI-Compliance manager, RM or designee.
Minimum Qualifications for MUWRP Jobs 2022
- Bachelor’s degree in Nursing, Midwifery or Medicine, or Diploma in Medicine and Nursing will be considered.
- At least 2 years of post-qualification professional experience, working in a clinical research setting.
- Current HSP and GCP certifications are a pre-requisite.
Added Advantage Education/Training:
- Ability to multi-task working with a medical research project
- Use of computers including word processing, spreadsheets, PowerPoint, email and Internet.
- Medical research experience and working in a Clinical trial regulatory setting
- Ability to demonstrate a good understanding of the HSP and GCP guidelines, and local guidelines for conducting research in human subjects as well as local approval processes for clinical trials.
- Ability to prepare and maintain essential and/or regulatory documents and study folders.
Supervisory controls: The individual will serve under the immediate supervision of the Continuous Quality Improvement & Compliance Coordinator.
Physical Ability: The ability to travel between the various MUWRP research sites.
How To Apply for MUWRP Jobs 2022
All interested and suitably qualified applicants should submit their applications through the link below.
Closing Date: Open until filled
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