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

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

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
This is a 24-month contract inclusive of an 18-month apprenticeship.


Band 4 Annex 21 for the duration of the apprenticeship: First 6 months - £20,380pa; Next 12 months - £20,697pa. On successful completion of the apprenticeship the salary will be £25,147pa for the remainder of the contract.


Apprenticeship eligibility criteria:


  • GCSE A*C/94 or Level 2 Functional Skills in English and Maths is required for successful completion of the course.
  • If you have previously studied a Businessrelated course at Level 3 or above, you will not be eligible. If you have already started your Business Administration apprenticeship with another employer then please contact the Apprenticeships Team to discuss eligibility.


You will be based within the Melanoma or Late Phase Research Team at The Christie, supporting many commercial, NCRN and clinician-led trials.


As an Apprentice Clinical Trials Coordinator you will be trained to be a valuable member of our team, providing support such as assisting the research nurses, consultants and trial administration/ coordination management team with various aspects of clinical trial administration/ coordination work including; 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.


The Christie NHS Foundation Trust is one of the leading cancer centres in Europe, offering high quality diagnosis, treatment and care as well as being at the forefront of cancer research and education.


As a key member of the Melanoma or Late Phase Research Team, you will be joining a busy, dynamic and supportive team.

The role is ideal for individuals keen to gain experience in clinical trials coordination.


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.
  • 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 guidelines.
  • Ensure that office/ trial related supplies are adequate and assist with the ordering process.
  • Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment Teams.
  • Demonstrates the
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