MRC/UVRI and LSHTM Uganda Research Unit Head of Research Governance Jobs
MRC/UVRI and LSHTM Uganda Research Unit Head of Research Governance Jobs
Job Purpose: The overall purpose of this role is to establish, maintain and oversee a research governance
framework and systems at the Unit that ensure compliance of the Unit’s research portfolio
with;
Regulatory requirements;
Ethical requirements;
International standards of best practice; and,
LSHTM/Unit Standard Operating Procedures (SOP) and Policies.
This includes all Unit research including laboratory research, data based research, human
studies, pre-clinical and clinical research, including clinical trials, device studies and other
interventional research at the field stations, partnering institutions, in the field throughout
Uganda and occasionally in the region.
The post holder is expected to establish internal ways of working and oversight mechanisms that achieve compliance with the above, and supports Principal Investigators, Project Leaders, Research Teams and Sponsors in achieving this.
The post holder also effectively oversees research risks and provides summary reports
that feed back into the corporate risk management structure.
The role is responsible for providing excellent services, support and advice to research teams.
Roles & Responsibilities
General duties:
Lead a team of research support specialists including Clinical Trial Monitors, Clinical Trial
Assistants and Research Compliance Auditors.
Ensure all research projects follow good research practice (GRP).
Ensure appropriate and approved participant information and informed consent documents are being used for all research involving human participants, their data and samples.
Establish departmental KPI and report progress to Unit Director quarterly.
Maintain information systems that track research projects in the different categories (data only, samples and data, volunteers, patients, interventional research and clinical trials) and their relevant stages (e.g. start-up, active/recruiting, active follow-up, data cleaning, close-out, reporting).
Retain oversight over Unit responsibilities and obligations towards external sponsors.
Engage and collaborate with other Unit support service department to ensure they deliver
work in compliance with applicable research requirements (e.g. Data Management, IT,
Archives, Clinical Diagnostic Laboratory Services, Biobank and other departments).
Ensure access to Unit data and biological samples (including the GPC) is controlled and
governed by appropriate procedures (on-site and off-site).
Work closely with the Unit’s Research Support Office to ensure department staff and
additional costs (such as ethics review and regulatory fees) are appropriately budgeted
for.
Review and develop proposals for the improvement of internal research review and approval processes that cover scientific excellence, strategic fit, appropriate resourcing, compliance and outputs.
Establish, maintain and monitor systems that ensure all research staff have the appropriate and documented level of skill and training to conduct their respective activities (in collaboration with Training Department and HR).
Facilitate all types of research audits, including internal LSHTM audits and internal/external sponsor audits.
Follow-up and resolve audit findings in a timely manner.
Support regulatory inspections – remotely and on-site.
Maintain systems that proactively identify non-compliances.
Promptly and formally report and address non-compliances (including serious breaches and policy violations) by overseeing root cause analysis and Corrective Action Preventative Action (CAPA) plans.
Follow-up non-compliances until resolution.
Provide ad-hoc and summary reports of non-compliances to Unit management, LSHTM London and MRC/UKRI as applicable.
Provide guidance and keep up to date Unit management and research teams on changes in national requirements or international standards ensuring that the Unit’s research portfolio continues to meet appropriate standards.
Facilitate study team applications for research approval to Uganda National Council of Science & Technology (UNCST).
Support teams in obtaining local and LSHTM ethics approvals.
Research Involving Animals:
Develop and implement structures that ensure appropriate regulation, control and
reporting of research projects involving animals.
Ensure highest procedural and ethical standards are being adhered to at the Unit.
Ensure the Unit complies with the 3Rs – Reduction, Refinement, Replacement.
Ensure animal housing and husbandry standards comply with applicable international
standards.
Facilitate integration with and reporting to LSHTM Animal Welfare and Ethics Review Body
(AWERB) in London.
Unit Laboratories:
Oversee compliance with
ISO15189, GCLP and other quality standards in the Unit laboratories, as applicable (in collaboration with CDLS department and other Unit laboratories).
Support re-accreditation and maintenance of relevant standards (including reaccreditation visits and audits).
Strategic planning:
Develop a formal strategy that ensures the department will meet the Unit’s evolving
needs and overarching strategy.
Anticipate department workload and regularly plan and adjust staff levels accordingly.
Develop plans for a Clinical Trial Support sub-department which is to be primarily funded
through external grants (this includes plans for employing in house Clinical Trial
Monitors).
Service Delivery:
It is important that the Unit’s Research Governance services are delivered in a customeroriented fashion. This post-holder ensures the department is;
Responsive.
Promptly communicating to users new developments such as new services, changes to services, service disruptions etc.
Pro-actively resolving issues.
Upholding high standards of professionalism.
Financial Management and Cost Recovery
The post holder is responsible for managing the department’s budget ensuring that:
The available budget is effectively utilized to achieve the department’s and Unit’s wider
objectives.
Expenditure is carefully monitored and does not exceeded the allocated amount.
Opportunities for cost recovery from research projects is maximized.
Line Management Responsibilities
The post is line managing a group of diverse and specialized staff.
The total staff number in
the department is anticipated to reach fully operational levels over the next year and the
department is expected to expand with a growing Unit research portfolio.
Roles in the department include;
Clinical Trial Monitors;
Clinical Trial Assistants; and,
Research Compliance Auditors.
The post holder ensures that
Staff are enabled to perform their assigned duties as expected.
Staff professional development is nurtured in line with the Unit’s and LSHTM’s capacity
building goals.
There is a positive and supportive work environment in the department.
Staff expectations are clearly communicated.
LSHTM Integration
Work towards integrating research governance and support services across LSHTM sites.
Arrange monthly meetings with Head of Research Governance & Integrity (London).
Provide routine and ad-hoc reports to Head of Research Governance & Integrity (London).
Streamline approval and oversight process through LSHTM Ethics Online (LEO) by developing Unit specific templates and decision tree that facilitates integration and central oversight of Unit projects.
Specifications:
Postgraduate degree or professional qualification in a relevant field.
Possession of a MSc in Clinical Trials or Clinical Trial Monitoring or PhD in a relevant
field is desired.
At least 5 years’ experience in a senior role in medical research related field.
Minimum of 5 years’ experience in the design, conduct, analysis and reporting of clinical trials.
Experience of collaborating with and managing multi-disciplinary project teams.
Experience of advising and influencing others at senior level.
Experience of budgetary control and reporting.
Experience with pre-clinical research, inc. research involving animals is an added advantage.
Should have expert knowledge of clinical trial methodology and regulatory requirements.
Should possess formal training in ICH-GCP.
Should have the ability to think strategically, for example in the planning of resources needed to oversee the portfolio of clinical trials to be undertaken at the Unit.
Ability to work co-operatively with key stakeholders including Uganda Government
agencies.
Excellent writing skills and experience drafting protocols, reports, funding applications
and regulatory documents.
Proven track record of successfully negotiating clinical trial regulations.
How to Apply
For more information and job application details, see; MRC/UVRI and LSHTM Uganda Research Unit Head of Research Governance Jobs
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