Clinical Trials Coordinator

Job Summary

We are looking to appoint a Clinical Trials Coordinator position to join a research delivery team within The Christie NHS Foundation Trust.

We are seeking an enthusiastic and highly motivated individual, who is wanting to expand their knowledge and interest in clinical trials administration, coordination, and data management. The role will enable you to get an understanding of clinical research, ICHGCP and clinical trial governance. We are looking for an individual with passion for applying organisational skills to day-to-day clinical trial coordination, whilst using their interpersonal skills to communicate effectively with a range of collaborators.

We have 1 role available, and the successful applicant will become part of the Lymphoma Research Team.

This is primarily an office-based role with the occasional opportunity for shadowing patient clinics, or other teams or departments. Post holders will not be required to undertake practical lab work.

Main duties of the job

The post holder will assist with the provision of a high quality and efficient administrative service. You will work with other 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 may 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, specialist 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.

Job Description
Job 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 that data is available and up to date for any meetings related to a clinical trial.
• If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
• Assist with preparation for audit and inspections within assigned teams.
• Assist with trial document archiving by following the Trust's archiving guidelines.
• Ensure that office/trial related supplies are adequate and assist with the ordering process.
• Undertake general administrative tasks as delegated by managerial representatives from the Research Division to contribute to the smooth running of the patient recruitment Teams.
• Demonstrates the agreed set of values and accountable for own attitude and behaviour.

Person Specification
Skills Essential

• Good written communication skills.
• Good understanding and demonstrated use of Microsoft Word and Excel.
• Accuracy and attention to detail.

Other Essential

• Ability to work to tight and/or unexpected deadlines.
• Flexible with ability to adapt to service requirements.
• Hardworking; ability to manage a busy workload.
• Ability to work unsupervised or as part of a team.

Qualifications Essential

• Diploma or administration experience.

Experience Essential

• Experience in administration including data management.

Knowledge Essential

• Knowledge of the clinical trials process.
• Familiar with GCP guidelines/EU directives.

Values Essential

• Ability to demonstrate the organisational values and behaviours.

Skills Essential

• Good organisational skills.
• Good interpersonal skills.
• Good oral communication skills.

Other Essential

• Tactful and diplomatic.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details
Employer name
The Christie NHS FT
Address
Lymphoma - Q00517
Manchester
M20 4BX
Employer's website
https://www.christie.nhs.uk/