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. Responsible for ensuring that all documentation required to file submissions to the Ethics committees and regulatory bodies are properly prepared, complete and consistent with
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
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
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
A diploma in a health related field such as Clinical Medicine, Nursing, Pharmacy or Public
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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