MRC Research Compliance Officer Jobs in Uganda

MRC Research Compliance Officer Jobs in Uganda



The Unit is an internationally recognised centre of excellence with dominant research themes in the areas of HIV and emerging infections, vaccines and immunity, and chronic diseases and cancer.

Through a multidisciplinary approach, intersecting basic science, epidemiological
research, social-behavioral research and the conduct of new intervention evaluation studies,
the Unit contributes knowledge on changing epidemics and diseases, the evaluation of
innovative health care options, treatment and prevention and the development of health
policy and practice in Africa and worldwide.

Following the signing of strategic transfer
agreements between the London School of Hygiene & Tropical Medicine (LSHTM) and the
Medical Research Council (MRC UK), the Unit formally joined LSHTM on 1st February 2018.


The exciting new partnership will boost research capacity into current and emerging health issues in Africa and throughout the world. The Unit is based at the UVRI Entebbe campus with established outposts in Kalungu, Masaka, Wakiso and Kampala Districts.


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 training 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 training; 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-todate Maintain an inventory of all regulatory documents
  • To generate applicable financial related requisitions


    Requirements


  • 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
  • At least 2 years work experience in a research setting.
  • Should have training in GCP and or GCLP.
  • Should have an understanding of local and international research guidelines.
  • Should have Knowledge of health research or should be interested in research.
  • Should have good 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 prioritize work


    How to Apply


    Interested and qualified candidates should apply online by 10th July, 2019


    For more information and job application details, see; MRC Research Compliance Officer Jobs in Uganda


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