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Clinical Trials Assistant

4 months ago

Manchester, United Kingdom The Christie NHS Foundation Trust Full time

Clinical Trials Assistant (Band 3) with scope to transition to a Clinical Trials Coordinator (Band 4) after a competency review

Please note that these posts are offered on fixed term contracts for 12 months at a time, 37.5 hours per week.

We are looking to appoint a Clinical Trials Assistant (Band 3) in the Renal and Oesophagogastric Research team within The Christie NHS Foundation Trust. The role has scope to transition to that of a Clinical Trials Coordinator (Band 4) following a competency review. The research teams form part of the Research and Innovation division and are made up of a multi-disciplinary group of staff who are dedicated to cancer research and treatment.

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.

The administrative team members each manage a portfolio of clinical trials with support from other colleagues. The day-to-day role includes entering data from patient visits, responding to trial queries, completing trial-related records, filing key trial documents, assisting with invoicing, working with members of the core Research and Innovation team, liaising with pharmaceutical contacts, and assisting colleagues with other administrative tasks.
We have a strong team working ethos and you will be required to work closely with different members of staff. The Clinical Trials Assistant role comes with full training, and the opportunity for additional training to support career development within the Trust.
The Renal and Oesophagogastric team works on studies including early phase, biomarker trials, real-world data, radiotherapy and will eventually be involved in innovative proton beam trials. The Christie’s research teams contribute towards pioneering research and innovation and we constantly work towards improving cancer care and patient outcomes. A role within our team is challenging but rewarding; we are a hard-working and friendly team with a passion for research and patient care.

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.

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

- Act as a point of contact for the Research and Development core team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to general trial conduct.
- Assist with the general administrative duties associated with the set up and initiation of rials within an assigned team, under the supervision of the Senior Clinical Trials Coordinators.
- Assist with completion of activity logs to enable 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.
- Assist with the processing of trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines, under the supervision of the Senior Clinical Trials Coordinators.
- Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements, under the supervision of the Senior Clinical Trials Coordinators.
- Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
- Assist the Clinical Trials Coordinators with the development of trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator.
- 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. This will be under t