Clinical Trials Coordinator

6 months ago

Manchester, United Kingdom The Christie NHS Foundation Trust Full time

Please note that this post is offered as a permanent contract at 37.5 h/week.

We are looking to appoint a Clinical Trials Coordinator (Band 4) to join the Observational and Supportive research delivery team within The Christie NHS Foundation Trust.

Applicants should meet all the essential criteria described in the job description as a minimum.

The post holder will assist with the provision of a high quality and efficient administrative service. You will work with Clinical Trial Coordinators and Data Managers on a wide aspects of clinical trials administration.

You will be assigned your own workload / portfolio of studies and help the team with the daily trials’ activity. These will include assisting with general administration associated with set up of clinical trials, regular trial management, completing activity logs to enable invoices being raised, entering data into data capture systems (electronic and paper) and maintaining electronic records to support the team.

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.

The observational and supportive research team covers a wide range of different disease types and the research landscape is constantly evolving. The portfolio consists of a range of studies including radiotherapy related research, anaesthetic research, genetics research, unmet patients needs research and bio-banking, providing a varied role for team members.

The Christie NHS Foundation Trust is one of the leading cancer centres in Europe, offering high quality diagnosis, treatment and care as well as being at the forefront of cancer research and education.

As a key member of the research team, you will be joining a busy, dynamic and supportive group who are passionate about clinical trials. Our studies cover a wide range of different disease types and the research landscape is constantly evolving.

Working with a team of Clinical Trials Coordinators, Research Nurses, and Investigators you will support the delivery of NCRN, academic trials and commercial trials. We put emphasis on individual’s and team’s development and encourage engagement from all team members into meetings and system improvement projects. An exposure to a variety of trials, tasks and processes enables professional and continuous growth.

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

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