Clinical Trial Coordinator /Cta Montreal

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop lifesaving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too. Working fully embedded within one of our medical devices clients, with the support of ICON right behind you, you’ll be at the heart of our client’s innovation.

Clinical Trial Coordinator

What you will be doing:

Clinical Trial Coordinator (CTC)

Trial and site administration:

• Clinical supply & non-clinical supply management, in collaboration with other country roles
• Track (e.g. essential documents) and report (e.g. Safety Reports)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Manage Labeling requirements and coordinate/sign translation change request

Document management:

• Document proper destruction of clinical supplies.
• Prepare Investigator trial file binders
• Obtain translations of documents
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Execute eTMF Quality Control Plan
• Update manuals/documents (e.g., patient diaries, instructions)
• Prepare documents and correspondence
• Assist with eTMF reconciliation

Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:

• Publish study results for GCTO and RA where required per local legislation
• Agencies submissions.
• In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
• Budgeting, Agreement and Payments:
• Support preparation of submission package for IRB/ERC and support regulatory
• Obtain, track and update study insurance certificates

Meeting Planning:

• Organize meetings (create & track study memos/letters/protocols)
• Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)