2 Entry Level Regulatory Officer Non-profit Career Jobs – Makerere University Walter Reed Project (MUWRP)
Job Title: Regulatory Officer (2 Career Jobs)
Organisation: Makerere University Walter Reed Project (MUWRP)
Duty Station: Kampala, Fort Portal and Kayunga, Uganda
About US:
The Makerere University Walter Reed Project (MUWRP) is a non-profit HIV research program that was established in 2002 as a result of a memorandum of understanding between Makerere University and The Henry M. Jackson foundation for Advancement of Military Medicine Inc. of USA (HJF). The primary purpose of MUWRP is to develop, evaluate and provide interventions to mitigate disease threats of public health importance to Uganda.
Job Summary: The Regulatory Officer 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.
Key Duties and Responsibilities:
- Tasked with 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.
- Working closely with ethical or regulatory body (in collaboration with the Pis) as well as initiating and maintaining pertinent correspondences.
- Tasked with tracking expiration of various protocol approvals at multiple ethical and regulatory bodies, drafting respective annual progress reports with timely submission as per institutional SOP.
- The jobholder will also be 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 may be required and ensuring clinic staff are annually trained on applicable SOPs.
- Keenly 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.
- Tasked with the 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
- Perform any other duties as may be delegated by the CQI-Compliance manager or designee.
Qualifications, Skills and Experience:
- The ideal candidate must hold a Bachelor’s degree in Nursing, Midwifery, Pharmacy
- Candidates with a Diploma in Medicine and Nursing are eligible to apply
- One year 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.
How to Apply:
All suitably qualified and interested candidates should download the application form, download here, attach it together with application letters, CVs, Photocopies of academic qualifications and three professional referees. The position number (Check top of advert) and preferred location should clearly be stated in the application letter.
Please send applications to:
The HR and Administration Manager,
Makerere University Walter Reed Project,
Plot 42 Nakasero Road.,
P.O. Box 16524 Kampala. Uganda
Deadline: 28th August 2017
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