Regulatory Submission Coordinator – Clinical Trials
Greece, Fully Remote
An exciting opportunity to join a leading clinical research organisation that specialises in complex clinical trials for the UK, Europe, the US, and the rest of the world markets. You will be supporting and coordinating cutting-edge Oncology clinical trials in early- and late-phase including working closely with senior team members to ensure the right strategies are defined.
As a Regulatory Submission Coordinator, you will be responsible for preparing, reviewing, and filing initial clinical trial applications to regulatory authorities and Ethics committees as well as ensuring submissions comply with applicable regulations and guidance documents.
As a regulatory submission coordinator, you will also advise sponsors on changing regulations and compliance requirements. Including being well-informed about the new EU CTR regulation and CTIS portal.
Responsibilities
· Supporting clinical trials in phases 1 to 4 with a focus on phase 2 and 3 trials in oncology.
· Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees.
· Ensure submissions comply with applicable regulations and guidance documents.
· Support any EU CTR transition and keep well informed about any changes to the new regulations.
Requirements
· A minimum of a Bachelor's degree in Life Sciences is required.
· At least one year of work experience in Regulatory clinical trials.
· Hands-on experience preparing, reviewing, and submitting regulatory documentation.
· Fluency in English.
· Strong communication skills, including being a confident speaker.
This is an excellent opportunity to join a leading organisation that works on complex CTAs globally and will offer you plenty of career development opportunities The role also comes with a full benefits package and is a great role to develop more regulatory experience.
For more information please email your CV to lucy.kirkaldy@cpl.com
- Agency: Cpl Life Sciences
- Reference: JO-2309-522499
Website: Cpl Life Sciences
- Posted: 11th September 2023
- Expires: 9th October 2023
