Main Duties and Responsibilities of the Trial Laboratory

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JOB DESCRIPTION
MSF UK and Ireland
Application checklist
Please check you have included the following documents in your
application email to recruitment.uk@london.msf.org by 8th January 2014 at
12pm:
CV
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Letter of motivation
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Equal Opportunities Monitoring Form

Clinical Trial Laboratory Coordinator
Manson Unit – TB-PRACTECAL Project
London Based
3 years fixed term contract (40 hours a week)
Job description
MEDECINS SANS FRONTIERES
Médecins Sans Frontières (MSF) is a leading international independent medical relief
organisation, dedicated to providing expert medical relief to vulnerable populations at
times of conflict or disaster. In over 70 countries worldwide, MSF provides both lifesaving emergency relief and longer-term assistance to make healthcare services
available to the most vulnerable or excluded communities.
MSF-UK is one of 23 offices and operational centres (OCs) in Europe, America, Asia and
Australasia, pooling funding, expertise and staff for field operations. There are currently
6 departments within the UK office (fundraising, communications, finance, programmes,
medical (called the Manson Unit (MU), HR) and an office in Dublin.
MSF's aim is to provide impartial assistance, on the basis of need alone, regardless of
ethnic origin, gender, creed or political affiliation. To maintain its independence from
political interference, MSF relies on donations from individuals around the world for at
least 50% of its income. This private funding gives MSF the freedom to respond to the
greatest needs as fast as possible.
As medical professionals, MSF field staff have a duty to try and protect their patients
from violence and abuse. MSF often chooses to speak out about gross violations of
humanitarian law against civilians in conflict, refugees, unaccompanied children and
other vulnerable groups, in an attempt to bring abuse to world attention.
The mandate of the UK section has traditionally been to provide technical, human
resources, financial and communications support to field operations. That support has
now evolved towards taking direct, medical and operational responsibility for specific
project development. MSF-UK’s income for the year ending 31 Dec 2010 was in excess
of 25 million, over 80% of which was spent directly on MSF’s overseas field
programmes. The UK office currently has around 50 full time staff working in the
London office and placed over 200 medical & non-medical staff to work in projects in
the field during 2010. The staff in the UK office are dynamic, enthusiastic, committed to
the aims of MSF and not afraid of “mucking-in” when necessary.
Manson Unit (MU)
The Manson Unit has been in existence for over 9 years, primarily working in
cooperation with MSF-Holland (MSF-H) now Operation Centre Amsterdam or OCA (MSF
Holland, Germany, Canada and UK/Ireland). It has proved itself as a model for
supporting MSF operations, having fulfilled its first task of ensuring that Artemisininbased Combination Therapy (ACT) was implemented across MSF-OCA programmes for
the treatment of malaria (2003-5). The role of the Manson Unit is to improve the quality
of MSF’s medical programmes.
Currently the Manson Unit has 9 staff. It identifies developments in the management of
medical issues such as tuberculosis (TB), HIV/AIDS, malaria and outbreaks of infectious
diseases and environmental contamination.
The Manson Unit helps MSF field projects put these changes into practice, monitors the
implementation of these changes and documents lessons learned from the experience.
Recently the Manson Unit has focused on implementing and improving TB screening
and treatment in MSF projects, integrating treatment for drug-resistant TB into all MSF
medical operations, providing HIV and TB care in unstable settings and improving and
advocating the treatment of TB in children.
TB-PRACTECAL Project management team
MSF is implementing the TB-PRACTECAL project to identify shorter, more effective and
less toxic M/XDR-TB treatment regimen(s) that are feasible to scale up using newly
registered drugs and new clinical entities. This principally involves the implementation
of a multi-centric (multi-operation centre) ICH-GCP level phase II/III clinical trial. MSF is
both the sponsor and investigator.
The Project management team (PMT) which is part of the Manson Unit, is the lead in
implementing this project. It consists of 8 members based in the London and other MSF
offices as well as in collaborating organisations. The core team includes the Project
Manager, the Clinical Trial Manager, and the study sites Principal Investigators (PIs). The
PMT maintains extensive collaboration with the London School of Hygiene and Tropical
Medicine, the Institute of Tropical Medicine in Antwerp, Drugs for Neglected Diseases
initiative, RESIST TB, The TB Alliance and other global organisations such as WHO.
Clinical Trial Laboratory Coordinator
Manson Unit, TB-PRACTECAL Project
Reports to:
TB-PRACTECAL Project Manager
Job purpose:
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To lead the laboratory components for the TB-PRACTECAL Clinical Trial including
participation in the protocol writing, SOP development and implementation,
assessment and advice to potential field sites on attaining Good clinical Practice
standards for laboratories (GCLP) and ongoing advice and technical supervision
of the laboratory components of the clinical trial.
Lead the upgrading process of MSF supported mycobacteriology laborotories to
GCLP standards for use in the clinical trial.
Main Duties and Responsibilities of the Trial Laboratory Coordinator (TLC)
Support to the TB-PRACTECAL project
Assume overall responsibility for the lab functioning of the multicentre study, the
success of the study being heavily dependent on the quality and robustness of lab
results. He/She will work closely with the agreed reference laboratory and their
dedicated principal investigator.
Achieve the above by:
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Ensuring that the trial design and protocol are feasible and appropriate from a
laboratory perspective, in collaboration with internal and external experts
Lead the development of the strategy and work plan, and implementation of the
mycobiology aspects of the clinical trial.
Act as Process Owner of SOPs and documentation for all laboratory procedures for
the trial
Lead the drafting, finalisation and amendments of the laboratory aspects of the
clinical trial protocol
Negotiating with relevant authorities regarding the bringing of field laboratory
practices in trial sites up to GCLP standards
Responsible for liaising with the reference laboratory and ensuring
implementation of quality assurance mechanisms for the network of laboratories
in the clinical trial
Ensuring OCA labs comply with GCLP standards: evaluation of current state,
supervising the upgrading to required standards, preparation for independent
audits, and responsibility for implementation of recommendations arising from
the inspections.
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Responsible for reviewing the major laboratory contracts and expenditures for the
clinical trial and making recommendations for approval.
Trial related technical management and supervision, coaching and training of MSF
OCA field-based lab personnel.
The position is hierarchically responsible to the TB-PRACTECAL Project Manager.
The post holder will be expected to be available to travel to Europe and field projects on
a regular basis (up to 50% of the time) and spend up to month or longer depending on
the needs especially in the upgrading process.
PERSON SPECIFICATION
Essential
 Knowledge of GCLP Standards for clinical trials confirmed by a recent GCP
certificate
 Demonstrable practical experience in working in a GCLP laboratory as part of a
GCP clinical trial
 Degree in Microbiology or the equivalent in other certification and experience
 Experience working in low/middle income context programmes
 Knowledge, skill and experience in protocol writing
 Knowledge of sample-taking and basic diagnostic techniques
 Advanced knowledge and experience of laboratory quality control procedures.
 Demonstrable (virtual) team-working skills as well as ability to work
independently
 Experience and affinity with training and coaching
 Excellent communication and interpersonal skills
 Fluency in written and verbal English
 Computer Literacy
 Ability to travel domestically and internationally
 Commitment to the aims and values of MSF
Desirable
 Advanced knowledge and experience in TB laboratory diagnostic procedures
including culture, DST and molecular testing.
 Higher level of experience in TB/HIV programmes
 Knowledge of additional languages particularly Russian
 Working in a multicenter trial
TERMS AND CONDITIONS OF EMPLOYMENT:
This is a full-time, fixed term position, and the requirement is to work 40 hours a week. The
salary for this post will be £40,162 inc. Inner London Weighting
Current Benefits at MSF UK and Ireland:
SALARIES
MSF UK & Ireland pays the salaries into the bank account on the 21st of each month.
FLEXITIME SCHEME
MSF UK & Ireland operates flexi time. The daily requirement for full time staff is to work 8 hours
plus half an hour for lunch with core hours between 9.30am-5.00pm and flexi time periods
between 8.30am – 9.30am and 5.00pm-6.00pm.
ANNUAL LEAVE
The MSF UK & Ireland holiday (annual leave) year runs from 1st January to 31st December.
Annual entitlement for full-time staff is 28 days per year in addition to UK bank holidays (pro
rata for part-time)
SICK LEAVE
On completion of the probationary period, employees of MSF UK & Ireland receive additional
benefits though our Group Income Protection Scheme and Group Life Scheme.
PENSION PLAN
On completion of the probationary period employees of MSF UK & Ireland can join the Group
personal Pension Plan. Members of the scheme contribute between 3% and 5% of their salary.
Contributions are deducted from salaries. MSF contributes 3% (for those paying 3 or 4 % of their
salary) and 10% for those paying 5%.
DEVELOPMENT OPPORTUNITIES
MSF UK & Ireland has an annual performance review process in place during which individual
development needs are discussed and training needs identified.
HOW TO APPLY – THE RECRUITMENT PROCESS
Timetable:
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Closing date for applications: 8th January 2014 at 12pm
Interviews: Week Commencing 13th January 2014
Start date: ASAP
To Apply
If you are interested in this position please send your CV and a letter of motivation explaining
how your skills and experience relate to the person specification to:
Beverly Gurevitz
Human Resources Officer
E-mail: Recruitment.UK@london.msf.org
Equal Opportunities Monitoring Form
Médecins Sans Frontières (MSF) UK is committed to the principle of equal
opportunity in employment. MSF UK/Ireland values the diversity of its workforce and
is firmly committed to creating a culture of dignity and respect at work that values
the rights of every individual.
We ask you to complete this form to assist us in monitoring who is applying for
employment with us, our adherence to equal opportunities best practice and our
progress towards identifying any barriers to diversity among our workforce.
This form will be separated from your application on receipt, and will not be
seen by the interview panel or used in any way for the purposes of
selection. If you are subsequently employed by MSF UK/Ireland it may be retained
upon your personal file. All information will be treated in the strictest confidence, and
in accordance with the Data Protection Act 1998.
SECTION A: AGE
Please tick the age group you belong to
 16 – 21
 61 – 64
 22 – 30
 65 +
 31 – 40
 41 – 50
 51 – 60
 I would prefer not to say
SECTION B: GENDER
What is your gender?
 Male
 Female
 I would prefer not to say
SECTION C: ETHNIC ORIGIN
What is your ethnic group? Choose ONE section from 1 to 5, and then tick the
appropriate box to indicate your cultural background.
1. White
 British
 Irish
 Any other White background (please specify)
2. Mixed
 White and Black Caribbean  White and Black African  White and Asian
 Any other Mixed background (please specify)
3. Asian or Asian British
 Indian
 Pakistani  Bangladeshi
 Any other Asian background (please specify)
4. Black or Black British
 Caribbean African
 Any other Black background (please specify)
5. Chinese or other ethnic group
 Chinese
Any other (please specify)
 I would prefer not to say
SECTION D: DISABILITY
The Equality Act 2010 defines a disability as ‘a physical or mental impairment which
has substantial and long term adverse effect on a person’s ability to carry out normal
day-to-day activities’. With this definition in mind, do you consider yourself to be
disabled?
 Yes
 No
 I would prefer not to say
If yes, please provide a brief summary of your disability if you wish to.
SECTION E: RELIGION AND BELIEF
Please indicate the term which best describes your religion/belief.
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Christian
Buddhist
Hindu
Jewish
Muslim
Sikh
Other (please specify)
No religion or belief
I would prefer not to say
SECTION F: SEXUAL ORIENTATION
Please indicate the term which best describes your sexual orientation.
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Bisexual
Gay man
Gay woman / lesbian
Heterosexual
I would prefer not to say
SECTION G: ADVERTISING
Where did you hear about this opportunity to work for MSF?
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MSF UK/Ireland Association
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MSF UK/Ireland website
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Agency (please specify)
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Other website (please specify)
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Newspaper (please specify)
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Magazine (please specify)
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Conference / Event (please specify)
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Word of mouth
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