Job Title: Regulatory Officer
Organisation: Makerere
University Walter Reed Project (MUWRP)
University Walter Reed Project (MUWRP)
Duty Station: Kampala, Uganda
Reports to: Head of Research
and Scientific Affairs
and Scientific Affairs
Position Number:
MUWRP-022/016
MUWRP-022/016
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.
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
Officer supports the expanded research program including research proposal
development. The Regulatory Affairs Officer 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.
Officer supports the expanded research program including research proposal
development. The Regulatory Affairs Officer 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:
Responsibilities:
·
Collect and coordinate various ethical and
regulatory documentation including initial submissions, continuing review
reports, SAEs, protocol deviations, and close out reports.
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.
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.
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.
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 with the PI and study coordinators to
maintain all essential and other regulatory documents accurately and
efficiently.
Work with the PI and study coordinators to
maintain all essential and other regulatory documents accurately and
efficiently.
·
Work in close liaison with the PI and study
coordinators to maintain protocol-specific source documents and CRFs, as well
accurate log(s) of these.
Work in close liaison with the PI and study
coordinators to maintain 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.
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.
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.
·
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.
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
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
Coordinate monitoring and audit visits in conjunction
with study coordinators
·
Develop and conduct employee regulatory training
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.
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.
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 Head of
Research and Scientific Affairs.
Other duties as may be delegated by the Head of
Research and Scientific Affairs.
Qualifications, Skills and
Experience:
Experience:
·
The applicant should preferably hold a
Bachelor’s degree in Nursing, Midwifery or Medicine, or Diploma in Medicine and
Nursing will be considered.
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.
A minimum of two years of post-qualification
professional experience, working in a clinical research setting.
·
Current HSP and GCP certifications are a
pre-requisite.
Current HSP and GCP certifications are a
pre-requisite.
·
Ability to provide technical review of data or
reports that will be incorporated into regulatory submissions to assure
scientific accuracy and clarity
Ability to provide technical review of data or
reports that will be incorporated into regulatory submissions to assure
scientific accuracy and clarity
·
Proficient in scientific writing
Proficient in scientific writing
·
Ability to multi-task and meet deadlines
Ability to multi-task and meet deadlines
·
Use of computers including word processing,
spreadsheets, PowerPoint, email and Internet.
Use of computers including word processing,
spreadsheets, PowerPoint, email and Internet.
·
Highly organized
Highly organized
·
Ability to organize , plan and prioritize work
Ability to organize , plan and prioritize work
·
Good communication skills (oral and written)
Good communication skills (oral and written)
·
Ability to work with a highly dynamic team
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.
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.
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.
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: 19th September 2016
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