Clinical Trial Co-ordinator

Job overview

The role of the Clinical Trials Coordinator will assist the Research Delivery Manager in the effective management of RD&I governance. The post holder will be responsible for supporting investigators with the smooth running of clinical trials in accordance with the appropriate quality systems, regulations and best practice. The role will predominantly focus on clinical research that is sponsored by the Trust.

Main duties of the job

Compile and manage clinical trial and ethical regulatory applications and substantial amendments.

Act as the central point of contact and administrative lead for clinical trial study teams, maintaining good communication between team members and the various trial committees.

Maintaining the trial master files, setting up TMF systems and devising appropriate proformas specific to trial management.

Liaison with the various trial centres, ensuring that they are compliant with trial standard operating procedures, protocols and regulatory requirements, and that they are being kept informed about trial developments; (this involves site visits and monitoring.)

Produce regular reports regarding trial progress for general distribution as well as reports to the ethics committee, oversight committees and sponsor as required.

Facilitating Good Clinical Practice compliance in the trial.

Development and implementation of trial documentation e.g. data collection and monitoring forms, trial specific operating procedures.

Preparing clinical trial teams, and documentation for regulatory inspections; coordinating inspections

To set up and implement systems and procedures for the start up and monitoring of clinical research projects.

To act as liaison between external organisations and the Trust in the initiation, approval and management of clinical trials.

To act as a resource for researchers applying for regulatory approvals, advising and assisting with applications.

Detailed job description and main responsibilities

Liaison with staff across the Trust informing them of trial activities going on in their departments and actively encouraging research collaborations.

Servicing trial committees - organising attendees, agendas, attending meetings, take and write up minutes where necessary.

Active participation in the trial oversight meetings, providing advice concerning trial regulatory and governance procedures.

Assist with the financial management of clinical trials, liaising with trial sponsors and finance ensuring financial records are kept up to date and contractual financial schedules are adhered to.

To ensure compliance with Trust RD&I standard operating procedures

Collecting case report forms/data and ensuring the completeness of trial data when necessary.

Investigating and locating missing data

Working with Clinical Trials Units in the development and management of clinical trial specific databases.

To liaise with departments across the Trust (including pharmacy and finance) to ensure all research projects are adequately planned and executed.

To liaise with pharmaceutical companies to facilitate commercial research collaboration.

Collate and report portfolio accrual data to the National database.

Visit the participating centres in the UK as needed to ensure good recruitment and record keeping (devising and assisting with trial recruitment drives).

Prepare ad-hoc reports and present details of trial progress at meetings as necessary.

Write trial promotional materials and organise continued trial promotion to prevent recruitment fatigue - e.g. newsletters, website, social media, awareness days etc.