Head of Research Governance NGO Careers – Medical Research Council (MRC UK) /UVRI and LSHTM Uganda Research Unit

Job Title:   Head
of Research Governance
 

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

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: 2nd September 2020 by 5:00pm.

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.

For more of the
latest jobs, please visit https://www.theugandanjobline.com or
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