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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