Clinical Trials Assistant

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 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.

An informal conversation to discuss the post is highly recommended.

**For further specific information on this post, please contact**:
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 main purpose of the role is to assist the clinical research team with all aspects of clinical trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies. The post holder will assist the Clinical Research Teams in daily trials activity according to the specific requirements of their assigned team(s).

The post holder will assist with the administration of clinical trials from feasibility to archiving, including (but not limited to):

- Assist with the general administration associated with set up of clinical trials.
- Assist with completion of activity logs to enable invoices to be raised.
- Assist with case report form completion and amendment processing to meet internal and external deadlines.
- Assist with 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.

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 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 trials 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 administrat