The Clinical Trial Coordinator will provide comprehensive support for the Drug Development Unit (DDU). They will manage the coordination and completion of essential trial documentation, with a focus on completing the trial-set up activities for the unit.

Shifts: 37.5hours/week, Monday-Friday 9am-5.30pm

Duties and Responsibilities

Documentation

• Collate essential site documents required prior to site activation
• Manage the creation, maintenance and archiving of the Investigator Site File (ISF)
• Maintain and track clinical trial documentation ensuring they meet GCP standards
• Coordinates the preparation of ISFs for Sponsor monitors, auditors and inspectors
• Create and complete tracking documentation as applicable
• Compile study documentation and reports as requested by the Sponsor

Regulatory

• To Prepare submissions and amendments to R&D, IEC and ARSAC
• To circulate amendment information to the team e.g., updated information sheets, study documentation etc.
• To prepare documentation for the review of studies.

Coordination

• Be the main point of contact for the Sponsor during study set-up.
• Plan and coordinate Sponsor initiated pre selection and site initiation visits
• Ensure the delivery of equipment, investigator site files and other required study supplies prior to site activation.
• Organise and request required staff accesses for the study portals.
• Give regular updates about the status of studies in set-up and inform the team once the study has been activated at site.
• Lead preparation of monitoring visits with external sponsors and initiate resolution of queries
• Assist in responding to enquiries from clinical trial sponsors and other organizations
• To understand the relevant study specific protocol requirements, identify and bring to the attention of the staff study non-compliance
• Perform ad hoc duties/projects as directed

Skills and Experience

• Educated to degree level ideally within Biological Sciences or similar
• Previous experience working within the Pharmaceutical/Clinical Research Organisation Industry is essential
• Previous experience in the start-up of Clinical Trials is highly desirable
• Excellent computer skills in key software e.g. Word, Excel, Powerpoint, email/outlook
• Current awareness of appropriate EU Pharmaceutical legislation e.g. Clinical Trial Directives (2001/20/EC), ICH GCP

About the individual

The successful candidate will be able to work both independently as well as within a team. They will be able to communicate with staff on all levels. Excellent communication and organisational skills are a must.