Clinical Trials Coordinator

We are looking to appoint a Clinical Trials Assistant (Band 3) to oneof our research teams within The Christie NHS Foundation Trust. The research teams form part of the Research and Innovation division (R&I). After a minimum of 6 months (post competency review) there is scope for this role to develop into a Clinical Trials Coordinator (Band 4) upon successful completion of a competency framework.

In order to support our growth as a centre of excellence in research, we are looking to recruit a Band 3 Clinical Trial Assistanttransitioning to a Band 4 Clinical Trials Coordinator to support our existing research staff. You will be based within the gynaecological research team. Thisteam support a large number of commercial, NCRN and clinician-led trials. We are seeking an enthusiastic and motivated individual who will be responsible for assisting the clinical research teams with all aspects of administration/ coordination relating to clinical trials according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and trust policies; the post holder would provide support to the Clinical Research Nurses, Clinical Trials Coordinators and Senior Clinical Trials Coordinators in ad hoc trials activity.

Once the individual have developed an experience base within clinical research and after a 6-month minimum competency review, there would be opportunity to move into the Clinical Trials Coordinator role where the individual(s) would then be responsible for assisting the research nurses, consultants and trial 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 largest cancer treatment centres in Europe, and an international leader in cancer research and development. We are one of the leading centres in the UK for clinical trials and radiotherapy research. Treating more than 40,000 patients a year, we are the first UK centre to be officially accredited as a comprehensive cancer centre. The Clinical Research Facility (CRF) at The Christie is also one of four specialist units in Manchester for experimental research that make up the NIHR Manchester CRF, providing us with the dedicated space and expertise required to deliver intensive and complex studies in safe environment.

In December 2018, The Christie became home to one of only two high energy NHS proton beam therapy (PBT) centres in the UK where we provide specialised treatment for UK patients with complex and hard-to-treat cancers who would otherwise be required to have this treatment abroad at centres in either Europe or in the USA. Plans have also been announced for the Paterson Redevelopment Project. The multi-million pound development will be led by The Christie on behalf of the Manchester Cancer Research Centre (MCRC), an internationally renowned and hugely successful partnership between The University of Manchester, Cancer Research UK and The Christie NHS Foundation Trust.

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 an