Jobs in Kalungu Uganda Medical Research Council (MRC UK) /UVRI AND LSHTM UGANDA RESEARCH UNIT Jobs in Kalungu Head Of Research Governan Jobs in Kalungu at Medical Research Council (MRC UK) /UVRI AND LSHTM UGANDA RESEARCH UNIT Head Of Research Governan Employment opportunities Medical Research Council (MRC UK) /UVRI AND LSHTM UGANDA RESEARCH UNIT
Job Title ⇒ Head of Research Governance
]https//www.blogger.com/blog/post/edit/5878136938400860152/20300515367933715
Organization ⇒ Medical Research Council MRC UK /UVRI and LSHTM Uganda
Research Unit
Duty Station Entebbe, Uganda
Position Code ⇒ HRG-820
Reports to ⇒ Unit Director Uganda & Head of Research Governance &
Integrity London
About US ⇒
The Medical Research Council MRC UK 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-behavioural 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.
Job Summary ⇒ The Head of Research Governance will 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.
Key Duties and 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.
⇗ Ensure research/trial teams adhere to all reporting requirements and
associated timelines.
⇗ Provide ICH-GCP and other relevant trainings on best research practice at
the Unit and occasionally to external stakeholder, as applicable.
⇗ Maintain records and oversight of all study/trial amendments, ensuring that
records are up to date.
⇗ Undertake any other duties within the grade as required by the Unit.
⇗ Represent Unit in meetings with external stakeholders on the national,
regional and global level.
Clinical Trial Oversight and Support
⇗ Establish formal green light process for drug and vaccine trials at the
Unit that ensures all necessary requirements are met prior to trial start.
⇗ Provide technical advice and input on protocols on appropriate clinical
trial procedures and regulatory/ethics requirements.
⇗ In collaboration with trial teams ensure external research locations are
fit-for-purpose in collaboration with Estates and CDLS departments.
⇗ Ensure trial teams are developing and implementing study-specific
procedures SSP.
⇗ Facilitate trial team applications for trial approval to the National Drug
Authority NDA.
⇗ Develop procedures that allow risk-based monitoring - both on-site and
remotely.
⇗ Oversee the development and implementation of formal, risk-based monitoring
plans.
⇗ Deliver internal clinical trial monitoring services independent from the
research team and support external monitoring visits as needed.
⇗ Ensure monitoring reports are generated and issued/received on time inc.
CAPA, as above.
⇗ Provide centralized clinical trial support in multinational clinical trials
and consortia.
⇗ Research Risk Management
⇗ Maintain formal Unit research risk registers to capture top-level research
risks.
⇗ Ensure research projects develop and keep up to date study/trial-specific
risk registers.
⇗ Ensure systems are in place and applied that minimize research risk across
the portfolio.
⇗ Ensure appropriate research agreements are in place funding agreement,
MDTA, collaboration/consortium agreements etc. prior to start of any research
activities.
⇗ Implement green light process for clinical trials at the Unit internal
sign-off for study start after confirming Trial Master File has all essential
documents, the approvals, in place.
⇗ Report quarterly to Unit Management Committee on non-compliances, research
portfolio and research risk.
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
re-accreditation 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.
⇗ Prepare business cases for initiatives that drive the development and
improvement of the department and its services.
⇗ Establish and maintain strong relationships and networks with partners in
Uganda, the region and globally to share best practice and to develop new
initiatives.
Service Delivery
⇗ It is important that the Unit's Research Governance services are delivered
in a customer- oriented 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.
⇗ Ensure services are effective across all field stations, which requires
regular direct interactions with staff outside Entebbe.
⇗ Take responsibility for the overall quality of the service delivery.
⇗ Lead the team's self-assessment process supporting the team in setting
targets and agreeing performance indicators for improvement.
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.
⇗ The post holder approves expenditure in line with the Unit's delegated
authority scheme currently up to £5,000.
⇗ There is full financial accountability.
⇗ That all opportunities to achieve maximum value for money are realized.
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 feel included and valued and their professional feedback and
proposals are heard and considered.
⇗ Staff expectations are clearly communicated.
⇗ Staff performance is regularly monitored.
⇗ Potential conflicts are resolved promptly and decisively, involving HR
support where needed.
⇗ Formal appraisals are conducted within the departments in line with the
Unit's schedule.
⇗ Applicable LSHTM and Unit HR policies are followed at all levels.
⇗ Participate in the development of equal opportunities, diversity and
inclusion.
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.
⇗ Maintain excellent and supportive working relationship with Head of
Research Governance at MRC Unit the Gambia at LSHTM.
⇗ Proactively participate in meetings, committees and working groups across
LSHTM sites and develop proposals to harmonise workflow.
⇗ Ensure that the LSHTM ethics committee and other oversight bodies have
overview of the Unit's research activities.
Environment
⇗ Develop strategies to reduce adverse environmental impact of the Research
Governance department.
⇗ Participate in carbon emission reduction activities across the Unit and
wider LSHTM.
⇗ Act as an advocate for the responsible and efficient use of resources.
Qualifications, Skills and Experience ⇒
⇗ The applicant must hold a 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 ⇒
Follow the link below to fill a form and submit your application
documentation
Click Here ]https//redcap.link/HeadOfResGovern
Filling the form more than once will lead to automatic disqualification. High
level of integrity while filling the form is required and will be considered
during shortlisting.
The applications should be addressed to
The Head of Human Resources,
MRC/ UVRI and LSHTM Uganda Research Unit,
P.O. Box, 49,
Entebbe, Uganda.
Deadline 2 nd September 2020 by 500pm.
Consider your application unsuccessful if not contacted within eight 8 weeks
after the closing date of the advert. Any form of lobbying at any stage will
lead to automatic disqualification. By submitting your personal information,
you consent to the MRC/ UVRI and LSHTM Uganda Research Unit holding and using
it in accordance with its recruitment policy and procedure. The Unit reserves
the right to verify documents attached with the relevant awarding institutions
to authenticate their validity.
NB Only shortlisted candidates will be contacted for interview. This position
is open to Ugandan nationals only. Strictly follow the application procedure
as failure to do so will lead to automatic disqualification.
Read and Apply Now Through
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Jobs in Kalungu Uganda Medical Research Council (MRC UK) /UVRI AND LSHTM UGANDA RESEARCH UNIT Jobs in Kalungu Head Of Research Governan Jobs in Kalungu at Medical Research Council (MRC UK) /UVRI AND LSHTM UGANDA RESEARCH UNIT Head Of Research Governan Employment opportunities Medical Research Council (MRC UK) /UVRI AND LSHTM UGANDA RESEARCH UNIT
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