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Job Title:       Research
Compliance Officer

Organization: Medical
Research Council (MRC) UK / UVRI 

Duty Station: 
Entebbe, Uganda

Reports to: Head
of Research Compliance and Quality Assurance

Position Code: RCO619

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 Research Compliance Officer will support
the Unit research program with a focus on ensuring that applicable local and
international requirements are met while executing research studies at the
Unit. S/He will liaise with the investigators and other research staff to
ensure compliance with local and international regulatory and ethical
guidelines/regulations. S/he will independently monitor research studies
conducted at the Unit to ensure the integrity of study related procedures and
processes.

Key Duties and Responsibilities: 

• Responsible for ensuring that all documentation required to file
  submissions to the Ethics committees and regulatory bodies are properly
  prepared, complete and consistent with applicable guidelines
• Responsible for safely keeping regulatory submissions both paper and
  electronic in clearly labelled files
• Participate in the development and review of standard operating
  procedures, case report forms, informed consent forms, screening/enrolment
  logs, roles and responsibility logs among others.
• Should ensure that local and international Ethics and Regulatory
  approvals are obtained in a timely manner
• S/he should conduct or participate in the conduct of site initiation
  visit, interim study monitoring visits and close out visits.
• In charge of tracking expiration of various protocol approvals at
  multiple ethical and regulatory bodies and ensuring that all ongoing
  studies have valid approvals
• Coordinate correspondences with the Sponsors, PI/Designee, ECs &
  Regulatory bodies
• Should keep track of all submissions and update PIs of their
  statuses from time to time
• Should participate in the preparation and maintenance of the investigator
  site file and trial master file
• Should liaise with the PIs/Designee to develop and track studies for
  expiry and work with the study team to ensure that continuous approval is
  sought prior to study expiry
• Seek clearance from Uganda National Health Research Organization
  (UNHRO) for manuscripts resulting from the Unit research work prior to
  publications
• Manage translation of Informed consent forms, survey tools and other
  applicable documents into local languages
• Should ensure that adverse events and protocol deviation are
  appropriately documented and submitted within the timelines set by the
  ethics and regulatory bodies.
• Ensure GCP/GCLP compliance of Unit studies
• Ensure that all study staff are appropriately educated, trained and
  experienced to undertake their duties.
• Responsible for updating and maintaining regulatory records of Unit
  studies
• Develop and conduct employee regulatory training in liaison with the
  Unit Training department
• Monitor investigator initiated studies to ensure absolute adherence
  to Good Clinical Practice in accordance with ICH-GCP standards,
  Declaration of Helsinki, Good Clinical Laboratory Practice, Local and
  International Regulatory requirements
• S/he is to work closely with the PIs/Designee to ensure proper
  adherence to approved protocol, source data and CRF entry verification,
  review of the investigator Site File etc.
• Act as a point of contact for external monitors. S/he will notify
  and prepare site research teams on upcoming external monitoring
  visits/audits
• S/he will be responsible for timely writing and dissemination of
  internal monitoring reports and following up on action items for both
  internal and external monitoring reports/audits
• Review internal and external monitoring reports to identify any
  trends for training needs and liaise with the training department to have
  the requisite trainings undertaken
• S/he will establish and document internal quality assurance and
  quality control processes/procedures.
• Oversee the maintenance 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.
• Ensuring that the operating licenses for the Unit Labs, Pharmacy and
  Clinics are up-to- date Maintain an inventory of all regulatory documents
• To generate applicable financial related requisitions

Qualifications, Skills and Experience: 

• The ideal candidate for the Medical Research Council
  (MRC) UK / UVRI) Research Compliance Officer job must hold a
  diploma in a health related field such as Clinical Medicine, Nursing,
  Pharmacy or Public Health
• Bachelor’s Degree in Clinical Medicine, Nursing, Medicine and
  Surgery, Public Health or Health Services Management is desired.
• A Masters Degree is an added advantage
• Two years of work experience in a research setting.
• Should have training
  in GCP and or GCLP.
• Should have an
  understanding of local and international research guidelines.
• Knowledge of health research or should be interested in research.
• Excellent communication skills
• Should be knowledgeable in use of Microsoft Office packages
• Excellent organisation and management skills
• Ability to work independently and meeting tight deadlines
• Should be highly organised and demonstrate ability to organise, plan
  and prioritise work.

Competencies:

Core:

• Personal Integrity
• Emotional Resourcefulness
• Ability to Learn
• Forward Thinking
• Reliability
• Team Player
• Openness to Others
• Independence
• Proactivity
• Results Orientation
• Thoroughness
• Concern for Excellence
• Flexibility Towards Work
• Development Oriented

How to Apply:

The candidates
should send their application letters, curriculum vitae including names, email
addresses and telephone contact details of three (3) referees, plus copies of
academic qualifications should be e-mailed to recruitment@mrcuganda.org.
NB: Please quote the following position code in the subject line of the email:
RCO619. Please also fill the following online form accordingly after submitting
the application documents on the e-mail above. Click Here

Address to:

The Human Resource
and Administration Manager

MRC/ UVRI and LSHTM
Uganda Research Unit

P.O. Box, 49
Entebbe.

Uganda

NB: Only
shortlisted candidates will be contacted for interviews. Note that academic
qualifications will be subjected to verification by the issuing
institutions. Please note that the Unit became part of the London School
of Hygiene and Tropical Medicine effective 1st February 2018.

Deadline: 12^th July 2019 by 5:00om

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