Entry Level Jobs – Regulatory Affairs Officer at Makerere University Walter Reed Project (MUWRP)



Organisation: Makerere
University Walter Reed Project (MUWRP)
Duty
Station:
  Kampala, Uganda
Reports
to:
Head of Research and Scientific Affairs
Position
Number:
MUWRP – 002
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. Activities include; vaccine development and
building of vaccine testing capability in Uganda, conducting of epidemiological
and basic research and provision of HIV Treatment, care and support in Kayunga,
Mukono and Buvuma Districts.
Job
Summary:
The Regulatory Affairs Officer offers support to the expanded research
program including research proposal development. The incumbent will provide 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: 
·        
Collect and coordinate various ethical and
regulatory documentation including initial submissions, continuing review
reports, SAEs, protocol deviations, and close out reports.
·        
Work closely with ethical or regulatory body (in
collaboration with the PIs) as well as initiating and maintaining pertinent
correspondences.
·        
Maintain regulatory files/databases and
chronologies in good order.
·        
In charge of tracking expiration of various
protocol approvals at multiple ethical and regulatory bodies, drafting
respective annual progress reports with timely submission as per institutional
SOP.
·        
Work closely with the PI and study coordinators to
maintain all essential and other regulatory documents accurately and
efficiently.
·        
Work in liaison with the PI and study coordinators
to maintain protocol-specific source documents and CRFs, as well accurate
log(s) of these.
·        
Responsible for 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.
·        
In charge of 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.
·        
Maintain current knowledge of FDA and
international regulations, standards and guidelines including GCP and ICH and
keep clinical staff appraised of pertinent changes
·        
Coordinate monitoring and audit visits in
conjunction with study coordinators
·        
Able to provide technical review of data or
reports that will be incorporated into regulatory submissions to assure
scientific accuracy and clarity
·        
Develop and conduct employee regulatory training
·        
Understanding and adhering to 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.
·        
Perform any other duties as may be delegated by
the Head of Research and Scientific Affairs.
Qualifications,
Skills and Experience: 
·        
The applicant should preferably hold a Bachelor’s
degree in Nursing, Midwifery or Medicine, or Diploma in Medicine and Nursing
will be considered.
·        
A minimum of two years of post-qualification
professional experience, working in a clinical research setting.
·        
Ability to organize, plan and prioritize work
·        
Current HSP and GCP certifications are a
pre-requisite.
·        
Using computers and computer systems
·        
Proficient in scientific writing
·        
Excellent communication skills
·        
Ability to respond in a timely manner and beyond
normal working hours on occasion
·        
Ability to multi-task and meet deadlines
·        
Use of computers including word processing,
spreadsheets, PowerPoint, email and Internet.
·        
Highly organised
·        
Excellent oral and written communication skills
·        
Ability to work with a highly dynamic team
·        
Demonstrable 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 Human
Resources and Administration Manager
Makerere
University Walter Reed Project
Plot 42
Nakasero Road.
P.O. Box
16524 Kampala. Uganda
Deadline:
18th January 2016
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