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The Institute of Cancer Research

By Monica Allen,2014-06-26 21:32
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The Institute of Cancer Research ...

    Trial Managers

Salary in the Higher Scientific Officer range (?28,538 to ?35,527)

    (Full time)

The Institute of Cancer Research, one of the world’s leading cancer research

    centres, is looking for experienced trial managers to join its expanding Clinical Trials and Statistics Unit (ICR-CTSU) at its Sutton site in Surrey. ICR-CTSU

    runs a portfolio of national and international phase III multicentre randomised controlled trials with a special emphasis in breast and urology cancer

    treatments.

    These posts offer an excellent opportunity for enthusiastic and well-motivated trialists to work in an academic environment at one of the leading National

    Cancer Research Institute accredited trials units. Successful applicants will be responsible for the coordination of a randomised trial in breast cancer.

    Duties will include:

    ? managing the day to day running of the trial

    ? promoting the trial to ensure successful recruitment

    ? co-ordinating and managing data from participating centres

Applicants should hold a first degree and have a good understanding of the

    principles of GCP, Data Protection and Research Governance. A proven

    track record in the organisation or management of randomised trials is

    essential.

Appointments will be on a fixed term contract for 3 years initially.

To apply please state where you saw this advertisement and enclose

    two copies of your covering letter and CV including the names and addresses of two referees together with a completed Equal

    Opportunities Monitoring Form to the HR Office, The Institute of Cancer

    Research, 123 Old Brompton Road, London SW7 3RP quoting reference

    number B227 . For a job description and equal opportunities form please

    visit our website at www.icr.ac.uk . Alternatively you may call our 24

    hour recruitment line on 020 7153 5475.

     thClosing date for applications: 5 November 2008

    The Institute of Cancer Research

    CLINICAL TRIALS AND STATISTICS UNIT (ICR-CTSU)

The Clinical Trials and Statistics Unit (ICR-CTSU) is based at the Sutton site of The SUTTON, SURREY

     Institute of Cancer Research which, together with the adjacent Royal Marsden

    Hospital NHS Foundation Trust, is one of the world’s leading comprehensive cancer research centres.

    The ICR-CTSU is one of nine UK National Cancer Research Institute (NCRI) accredited trials units and a UK Clinical Research Collaboration (UKCRC) registered unit. Our aim is to initiate, conduct and analyse national and international randomised clinical trials of cancer treatment designed to have a direct influence on routine clinical practice within the National Health Service and overseas. Widespread participation and national collaboration are essential for such trials to succeed; therefore close links with other cancer trials offices and clinical centres throughout the UK are central to the working practices of the ICR-CTSU. Over 100 UK hospitals participate in trials currently run by the ICR-CTSU, many centres entering patients into several trials. Our main interest and expertise is in early breast cancer where we are responsible for a major component of the UK’s portfolio of academic-led non-surgical phase III trials of adjuvant systemic and local therapy. We also have an expanding portfolio of urology trials and of radiotherapy technology trials. Additional current areas of interest are mesothelioma and head and neck cancers.

    The ICR-CTSU currently employs around fifty staff including statisticians, trials managers/co-ordinators and research, IT and administrative support staff.

    The ICR-CTSU works closely with the Royal Marsden Hospital NHS Foundation Trust. Collaborations also exist with the International Collaborative Cancer Group based at Imperial College, London.

    More information about the ICR and the ICR-CTSU can be found on our web site (www.icr.ac.uk).

    INSTITUTE OF CANCER RESEARCH

    JOB DESCRIPTION

JOB TITLE Trial Manager

    SECTION: Clinical Trials, Clinical Trials & Statistics Unit (ICR-

    CTSU)

    GRADE Higher Scientific Officer RESPONSIBLE TO: Senior Trials Manager ACCOUNTABLE TO: Judith Bliss (Director, ICR-CTSU)

    LINE MANAGER FOR: Data Manager(s) and/or Administrative Officer(s)

BACKGROUND

We require Trial Managers to coordinate several randomised controlled clinical trials

    in breast cancer, including a large (4000+ patient) chemotherapy trial which opened

    to recruitment in December 2005, and two new peri-operative trials (one recently

    opened, the other in set up) which represent a novel approach to adjuvant treatment.

    Further details about each trial are given as an attachment to this job description.

OBJECTIVES

To oversee the day-to-day management of an individual trial. Overall responsibility

    for the conduct of each trial is shared with the Chief Investigator (CI) and the principal

    statistician (Director) responsible for the scientific progress of the trial. The post

    holder will work closely with other members of the trial team including statisticians,

    data managers and administration officers. Additionally, they will be expected to

    contribute to the set up of new research initiatives.

RESPONSIBILITIES/DUTIES

All responsibilities and duties are carried out in accordance with ICR-CTSU

    standard operating procedures.

Trial initiation (if applicable)

    1. Preparation of trial documentation e.g. protocols, trial guidance notes, case

    report forms (CRFs), and patient information sheets.

    2. Preparation of applications for Multicentre Research Ethics Committee

    (MREC) approval.

    3. Preparation of applications for Clinical Trial Authorisation by the Medicines

    and Healthcare products Regulatory Authority (MHRA).

Trial management

    4. Manage the day to running of the trial, ensuring the trial is conducted

    according to current Good Clinical Practice guidelines in accordance with the

    EU Directive for Clinical Trials and other relevant legislation (e.g. Data

    Protection Act).

    5. Liaise closely with scientists collaborating on associated sub-studies e.g.

    tissue/blood collection, quality of life and health economic studies, developing

    grant proposals and further MREC submissions as appropriate. 6. Oversee the day-to-day conduct of associated sub-studies.

    7. Write monthly progress reports to the Trial Management Group (TMG). 8. Service the Trial Steering Committee and TMG by organising meetings with a

    prepared agenda and full written record of meetings. 9. Organise meetings of the Independent Data Monitoring Committee.

    10. Update trial documentation as necessary e.g. protocols, trial guidance notes,

    case report forms (CRFs) and patient information sheets. 11. Prepare and submit amendments under the guidance of the CI to MREC and

    the MHRA as appropriate.

    12. Draft regular progress reports e.g. to funding bodies, NCRI Clinical Studies

    Groups, MREC, MHRA.

    13. Perform start up and monitoring visits at centres to explain and ensure

    adherence to trial procedures.

    14. If applicable, liaise closely with other offices involved in the management or

    running of the trial.

    Trial promotion

    15. Liaise with collaborators and potential collaborators to promote trial

    recruitment.

    16. Draft and circulate regular newsletters.

    17. Plan, organise and give presentations at meetings of trial participants. 18. Contribute to the preparation of abstracts, posters and manuscripts. 19. Promote the trial at national scientific meetings with poster displays/abstract

    submission.

    Data management

    20. Maintain up to date trial guidance notes for participating centres and

    collaborating trials offices.

    21. Maintain, manage and follow timely and efficient procedures for the collection,

    computer entry and verification of all patient data. 22. Maintain record management systems for all trial material.

    23. Liaise with hospital staff to ensure trial procedures are being followed to

    promote high quality data.

    24. Perform data monitoring visits on random subsets of patients/centres, as

    required.

    25. Prepare data for interim and/or full analysis performed by the Trial Statistician.

    Staff management

    26. Management and/or supervision of other staff members working on the trial,

    e.g. data managers and administrators 27. Oversee trial specific activities of relevant staff at collaborations trials units.

General duties

    28. Enter patients into randomised clinical trials (telephone, fax, e-mail, on-line),

    in some cases this will involve resolving queries with the clinician regarding

    the eligibility of the patient for trial entry. The ICR-CTSU’s randomisation

    telephone line operates 9am-5pm each working day on a rota basis.

    29. Attend and contribute to ICR-CTSU’s monthly journal review meetings, team

    meetings and trial coordinator meetings.

    Any other duties as may be required which are consistent with the nature and

    grade of the post.

APPOINTMENT DETAILS

    This is a full-time post (35 hours per week.), Monday to Friday funded by Cancer Research UK. In general ICR-CTSU staff work from 9 am to 5 pm with a one hour lunch break. However, the post holder may be required to work outside these hours to meet deadlines. It may also be necessary for the post holder to be available for occasional evening meetings and for meetings to include overnight stops.

    Appointment will be on a Fixed Term Contract for 3 years in the first instance.

    Appointment will be to the Higher Scientific Officer (HSO) scale depending on skills, qualifications and experience. The HSO scale commences at ?28,538 pa rising to ?35,527 pa. Progression through the salary scale will be performance related. In addition the salary scales are reviewed annually to reflect cost of living increases.

    The annual leave entitlement is 25 days pa rising to 30 days pro rata. In addition there is a pro rata entitlement to 11 days public and privilege holidays.

    The post is based at the ICR site at Sutton, Surrey. The site has free on-site car parking facilities for all ICR staff. There are also on-site sports and social facilities including a number of canteens, a squash court, swimming pool, gym and a tennis court.

FURTHER INFORMATION

    You may contact a member of the ICR-CTSU for further information by emailing ctsu@icr.ac.uk

    This job description is a reflection of the present position and is subject to review and alteration in detail and emphasis in the light of future changes or developments.

Prepared by: CS Sep 08

    TRIAL OF ACCELERATED ADJUVANT CHEMOTHERAPY WITH

    CAPECITABINE (TACT2)

    TACT2 first opened to recruitment in December 2005, and is a phase III randomised multicentre trial which having recruited over 4000 breast cancer patients in under 3 years from over 100 hospitals throughout the UK makes it one of the largest breast cancer chemotherapy trials in the national portfolio.

    Earlier UK research identified 4 cycles of Epirubicin followed by 4 cycles of CMF chemotherapy as a current best standard chemotherapy treatment for early breast cancer. Data from US research has shown that accelerated (dose dense) chemotherapy may be more effective than chemotherapy given in conventional 3 weekly cycles. However these data are based on the acceleration of a sequence of chemotherapy drugs, and it is not known whether acceleration improves the effectiveness of all of the chemotherapy drugs tested, or just one of them. TACT2 will test the benefit of accelerating Epirubicin.

    Capecitabine is a chemotherapy drug used to treat advanced breast cancer, and the toxicity profile suggests that Capecitabine is likely to be safer than classical CMF. TACT2 will evaluate whether substituting Capecitabine for CMF will reduce treatment toxicity yet still be at least as effective as CMF.

    Patients are entered into the trial via one of 4 UK trials offices, with the Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU) acting as the main coordinating trials office (other participating trials offices are based in Edinburgh, Leeds and Birmingham).

    The emphasis of the trial management role is to ensure the quality of all trial data, which will include training research staff based in participating centres throughout the UK. The post holder will play an important role in maximising and monitoring the collection of paraffin embedded material and blood samples for associated biological studies; this requires close collaboration with researchers in Edinburgh, and with pathologists throughout the UK. A Quality of Life (QL) study and Health Economic Evaluation are being conducted, and the post holder will work closely with the QL study coordinator based in Edinburgh to ensure the integrity of the QL study.

    The trial manager will be part of a team comprising of two/three data managers, trial statisticians and an administrator who work closely with the chief investigator (currently in Leeds) and two other clinical coordinators (Cardiff and Glasgow). The post holder will develop strong links with research nurses and data managers at centres throughout the UK.

TRIAL OF PERI-OPERATIVE ENDOCRINE THERAPY - INDIVIDUALISING

    CARE (POETIC)

The POETIC study is a phase III open label randomised trial of 4000

    postmenopausal women with ER positive breast cancer, to be conducted through

    approximately 100 hospitals throughout the UK. Funding and approvals for this trial

    are now in place, and the first centre was recently opened to recruitment.

    Recent research has shown that the tumour marker Ki67, when measured two weeks

    after starting treatment with an aromatase inhibitor is a better predictive factor in

    determining long term outcome of breast cancer in patients than Ki67 in untreated

    patients. These data now require validation in a larger trial. If confirmed, then the

    relatively simple measurement of Ki67 following two weeks of treatment could be

    used to predict which patients are going to do well and which require additional or

    alternative therapies.

    For some years there has been speculation whether short duration pre-operative

    endocrine therapy prior to surgery might improve outcome, through reduction in the

    proliferative capacity of tumour cells released at surgery or by other speculative

    mechanisms. This hypothesis is also being tested within POETIC.

POETIC will therefore:

    ? evaluate whether 4 weeks peri-operative endocrine therapy improves long-

    term outcome compared with standard adjuvant treatment.

    ? confirm whether proliferation rate (Ki67) 2 weeks after starting endocrine

    therapy predicts for long-term outcome in postmenopausal women with

    hormone receptor positive breast cancer better than in untreated patients.

    ? determine whether molecular profiling 2 weeks after starting endocrine

    therapy predicts for long-term outcome in postmenopausal women with

    hormone receptor positive breast cancer better than in untreated patients.

The main challenges of this trial will be to engage the majority of UK breast surgeons

    and radiologists, and facilitate the collection of biological specimens.

EFFECT OF PERIOPERATIVE ANTI-HER2 THERAPY ON EARLY BREAST Use of anti-HER2 therapy perioperatively may improve the outcome of women with CANCER STUDY - BIOLOGICAL PHASE (EPHOS-B)

     HER2 positive early breast cancer, more than a third of whom will be expected to

     have occult micrometastatic disease at the time of surgery. There is evidence that removal or irradiation of primary tumours leads to the size of concomitant metastases increasing and anti-HER2 therapy may counter such effects. Patients often have a 6 week delay between diagnosis and starting chemotherapy, these patients may benefit from active anti-HER2 therapy during this time which could help prevent eventual relapse of their tumour.

    EPHOS will employ a 2-phase design. In the biological phase (EPHOS B), 250 patients, newly diagnosed with HER2+ve breast cancer and awaiting surgery will be recruited to compare the biological effects of perioperative treatment with herceptin or lapatinib with each other and with a no treatment control group.

    Subject to the results of the first phase, and on the advice of the Independent Data Monitoring Committee (IDMC), the trial will be extended to a clinical phase (EPHOS C) evaluating the effect of such treatment on long term disease outcome (expectation of approximately 2700 further patients). Recruitment to the trial will continue pending the IDMC review of the results of the biological phase and the trial arms to be extended into the clinical phase will be guided by pre-specified decision rules.

    Funding for EPHOS B is now in place, and the study is currently in development. It is anticipated that the study will open to recruitment late in 2008.

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