Vacancy title:
2 Regulatory Officer

Jobs at:
Makerere University Walter Reed Project ( MUWRP )

Deadline of this Job:
28th August 2017

Duty Station:
Kampala, Uganda

Job details:
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.

MUWRP seeks to fill the following position:

Position title: 2 Regulatory Officer.

Job Summary: The candidates will serve as Regulatory Officers for the Makerere University Walter Reed Project and will provide assistance to the Continuous Quality Improvement and Compliance Manager 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:

• Preparing and timely submit 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 Pls) 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 (electronic and hard copy) accurately and efficiently.
• Maintaining and tracking version control of protocol-specific source documents and CRFs, as well accurate log(s) of these.
• Developing SOPs and source documents as maybe required and ensuring clinic staff are annually trained on applicable SOPs.
• Tracking SOP approvals, revisions and training for all applicable staff.
• Ensuring only current IRB approved versions of protocols, informed consents, recruitment material etc (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
•  Maintaining and tracking applicable practicing licenses as per local, international and sponsor requirements/ regulation.
•  Coordinating and assisting in Site Monitoring Visits
•  Other duties as may be delegated by the CQI-Compliance manager or designee.

Required Education, Knowledge and Experience:

•  Bachelor's degree in Nursing, Midwifery, Pharmacy
• Candidates with a Diploma in Medicine and Nursing are eligible to apply
• At-least 1 years of post-qualification professional experience, working in a clinical research setting. Current HSP and GCP certifications are a pre- requisite.
• Ability to use of computers to include word processing, spreadsheets, PowerPoint, email and Internet.
• 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 and Compliance Manager. Physical Ability: The ability to travel between MUWRP’s headquarters in Kampala and other MUWRP sites.

Job application procedure
Interested candidates should submit a MUWRP Application form, Application letter, Photocopies of academic qualifications and Curriculum Vitae with 3 referees to:
The Human Resource & Administration Manager
Makerere University Walter Reed Project
Plot 42 Nakasero Road.
P.O. Box 16524 Kampala.
The closing date for receiving applications is 28th August 2017
ONLY SHORTLISTED CANDIDATES WILL BE CONTACTED.