Clinical Trials Coordinator

Job overview

We are looking to appoint a Clinical Trials Coordinator (Band 4) to the Rare Tumour 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 have demonstratable working or academic knowledge of clinical trials/GCP and meet all the essential criteria on job description as a minimum. We are looking for a candidate with good organisational, communication skills and administration experience.

Main duties of the job

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.

Please see the attached job description for a more detailed description of the tasks this job will involve.

Detailed job description and main responsibilities

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 agreed set of values and accountable for own attitude and behaviour.

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.