Clinical Trials Assistant - Manchester, United Kingdom - The Christie NHS Foundation Trust

The Christie NHS Foundation Trust
The Christie NHS Foundation Trust
Verified Company
Manchester, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description

We are looking to appoint 2 Clinical Trials Assistant Band 3 to band 4 (permanent & fixed term) development role to the Haematology Research Team within The Christie NHS Foundation Trust.

The research teams form part of the Research and Innovation division.


We are seeking an enthusiastic, motivated and experienced individual who will be responsible for assisting the research nurses, consultants and trial coordination management team with various aspects of clinical trial administration/ coordination.

Applicants should meet all the essential criteria described in the job description as a minimum.


You will be responsible for data management, case report form completion, invoicing, communication with trial sponsors, monitors and the wider research community, maintaining electronic records to support the team and assisting with the set-up of new studies.


You will be liaising with many different members of staff including internal service departments, central R&I office colleagues, clinicians and research nurses, as well as external collaborators, i.e.

trial sponsors, monitors and the wider research community, so good communication and interpersonal skills are key.

The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year.

We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country.

We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services.

We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK


DUTIES AND RESPONSIBILITIES
The specific responsibilities will depend on the requirements of each team, but may


include:


  • Act as a point of contact for the core Research and Development team, study
sponsors, clinical research organisations and specific research teams,
communicating directly with them regarding data queries, monitoring visits
and other enquiries relevant to trial set up and general trial conduct.

  • Set up and initiation of allocated trials within an assigned team, under the
guidance of the Senior Clinical Trials Coordinators.

  • Track all payments throughout each clinical trial including completion of
activity logs and requesting invoices to be raised.

  • Maintain investigator site files and essential documentation in accordance
with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all
times.

  • Process trial amendment submissions in accordance with ICH-GCP and Trust
SOPs and timelines.

  • Provide administrative support to the Clinical Research Nurses and Principal
Investigators for safety reporting in accordance with protocol requirements.

  • Complete team reporting mechanisms (i.e. recruitment activity logs, patient
visit logs, costing spreadsheets, case report form trackers and electronic
proformas).

  • Produce trial workbooks for review by the lead Clinical Research Nurse and
Principal Investigator for assigned studies and ensure version control is
maintained.

  • Ensure collection of clinical case notes for all patients, so that these are
available as needed, for monitoring and audit purposes.

  • Complete case report forms as per sponsor requirements, and liaise with
clinical trial monitors to ensure the data sent is valid and their requirements
are met at site monitoring visits.

  • Cross check, confirm data and complete query resolution with sponsors and
third parties in a timely manner.

  • Completion of clinical trial specific databases with data from various sources
such as questionnaires, hospital records and other electronic and paper
sources.
Clinical Trials Coordinator

  • Band
  • March 202
  • Liaise with internal and external NHS staff regarding case notes, data
collection, archival tumour blocks, mortality data, and other general trial
activities, which may be confidential and sensitive in nature.

  • Arrange shipping and delivery of relevant trial data and documents including
import/export of tumour blocks, ECGs and copy scans.

  • Arrange team and trial related meetings as required, producing minutes in a
timely manner.

  • Ensure that data is available and up to date for any meetings related to a
clinical trial.

  • If required attend project related meetings, investigator meetings (abroad or
teleconferences, as necessary) to convey the relevant information to the
study team.

  • Assist with preparation for audit and inspections within assigned teams.
  • Assist with trial document archiving by following the Trust's archiving
guideline
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