The Christie NHS FT

Radiology Clinical Trials Coordinator

This job is now closed

Job summary

The main purpose of the role is to provide comprehensive data management and administrative support to the Radiology Clinical Trials Team according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.

The successful post holder will have experience working within clinical trial delivery within an NHS site and preferably an understanding of oncology research combined with an understanding of radiology techniques and imaging used.

Main duties of the job

The main purpose of the role is to provide comprehensive data management and administrative support to the Radiology Clinical Trials team according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.

The post holder will:

Manage and maintain the clinical trials database.

Assist with the efficient and timely set up of clinical trials.

Assist with the tracking and raising of invoices.

Provide support with maintenance and quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.

Assist with preparation for audit and inspections within assigned teams.

General trial-related communication in accordance with the Data Protection Act.

Assist with maintenance of clinical trial documentation.

Manage own workload for daily trial activity including case report form completion and amendment processing to meet internal and external deadlines.

About us

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.

Date posted

08 July 2024

Pay scheme

Agenda for change

Band

Band 4

Salary

£25,147 to £27,596 a year per annum

Contract

Permanent

Working pattern

Full-time

Reference number

413-84886-RI-MS

Job locations

Radiology Research - Q01558

Wilmslow Road

Manchester

M20 4BX

Job description

Job responsibilities

DUTIES AND RESPONSIBILITIES

The specific responsibilities will depend on the requirements of each team, but may include:

Attend project related meetings, or teleconferences, as necessary, producing minutes in a timely manner.

Assist with general preparation for audit and inspections within assigned team.

Set up and initiation of allocated trials within an assigned team, under the guidance of the Senior Research Project Manager.

Provide administrative support to the Principal Investigators and delegated trials team for safety reporting in accordance with protocol requirements.

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.

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.

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

Archive all trial radiology documents following the Trusts archiving guidelines.

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

Act as a point of contact for the Research and Innovation core team, external study sponsors, contract research organisations (CROs) and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to general trial conduct.

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 Principal Investigator for assigned studies and ensure version control is maintained.

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.

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.

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

Maintain the radiology clinical trials database including accurate patient data entry, imaging, and resolution of discrepancies between Trust information systems (CRIS, CWP) for patients taking part in clinical trials associated with radiology.

Produce copy scan images for research purposes ensuring GCP and GDPR requirements are followed in the production and transfer of images.

Maintain tracking systems i.e. attendance and appointment stats, copy scan logs, clinical trials database maintenance in response to service needs. Contribute to continuous developments and the future development of the radiology clinical trials service.