Head of Research Compliance and Quality Assurance Job Placement – Medical Research Council MRC/ UVRI UK

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Organization: Medical Research Council/ Uganda Virus Research Institute (MRC/UVRI)
Duty Station: Entebbe,
Uganda
Reports to: Unit Director
Position Code: RCQ817
About Us:
The MRC/UVRI Uganda Virus Research Unit on AIDS was established
following a request in 1988 from the Uganda Government to the British
Government for collaboration on the research of HIV (Human Immunodeficiency
Virus) infection and AIDS (Acquired Immunodeficiency. The Unit is a center of
excellence in HIV/AIDS related research. It conducts large-scale
epidemiological and intervention studies, clinical trials, virological and
immunological research and behavioural studies, and has generated a wealth of
research results that have been used to inform policy and practice that have
led to a large number of scientific publications in peer reviewed journals over
time.
Job Summary: The Head of
Research Compliance and Quality Assurance will manage an independent research
compliance and quality assurance office that supports all clinical and
laboratory studies in the Unit, ensuring correct and timely conduct of the
studies according to approved protocols and ensuring regulatory, GCP / GCLP and
ISO 15189 compliance. The incumbent will be responsible and line manage the
clinical research coordinator, the Laboratory Quality Assurance manager and the
study coordinators.
Key Duties and Responsibilities:  
  • Tasked with understanding the objectives
    and design of studies carried out in the unit and advises on unit QA/QC
    processes.
  • Conducts protocol related trainings as
    required.
  • Writes and reviews standard operating
    procedures (SOPs and MOPs)
  • Providing input into study design if
    required.
  • Render support in planning and
    implementation of Unit studies
  • Update and maintain records on progress of
    studies within the Unit and assess impact of interventions.
  • Actively participate in internal and
    external audit activities
  • Ensure laboratory quality management
    system is functional
  • The jobholder will identify challenges in
    study implementation, suggesting corrective action where appropriate
  • Coordinate appropriate and timely
    regulatory approvals of Unit studies
  • Oversee maintenance of required regulatory
    documentation
  • Ensure GCP/GCLP compliance of Unit studies
    and GCP & HSP certification of study staff.
  • Provide support and document external and
    internal monitoring activities of ongoing studies
  • Supervise follow up actions from
    monitoring activities
  • Actively participate in site visits when
    required.
  • Work closely with the Research Support
    Office, safety officer and laboratory managers in compliance requirements



Qualifications, Skills and
Experience: 
  • The applicant must hold a Bachelor’s
    Degree in bio-medical, MBChB, or related scientific research field,
    Training in GCP / GCLP and in Human Subjects Protection.
  • MPH, MSc Clinical Trials or laboratory
    sciences
  • At least two years of post qualification
    research experience preferably in a leadership role in a GCP compliant
    study or GCLP accredited laboratory
  • Previous experience in development of
    study protocols, Standard Operating Procedures, Study Operation and / or
    Pharmacy or Laboratory operation manuals
  • Essential: Knowledge of research design
    and research methodology
  • Knowledge of international and local
    requirements for research involving human subjects is desirable
  • Ability to understand individual tasks and
    role within the larger context of overall research program
How to Apply:
All suitably qualified candidates should send their application
letters, curriculum vitae including names, email addresses and telephone
contact details of three (3) referees and copies of academic qualifications
should be emailed to: recruitment@mrcuganda.org. Please quote the Position Code
in the subject line (Check Top of Advert).
Deadline: 25th August
2017
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