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PRA Health Sciences: Senior Clinical Trial Coordinator – Regulatory

PRA Health Sciences

This is a Full-time position in Montreal, QC posted September 28, 2020.

We believe that our people are the future of the industry.

We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans.

If you’re ready to be a part of something inspiring join us and Discover Your PRA.

Who are we?

We Are PRA.

We are 17,000+ employees strong, operating in more than 90 countries.

We are committed to saving lives and we are constantly striving to be the best at what we do.

Our impact is real and we see it every single day.

We are getting live saving drugs into the hands those who need them most.

Who are you?

You are a leader that isn’t afraid to delegate, but also isn’t afraid to get your hands dirty.

You look for new and innovative ways to problem solve.

You are the ultimate planner and coordinator and are an excellent communicator.

You have a serious passion for clinical development.

You never settle for what is, but are always pushing clinical development forward to what it could be.

You motivate others to do the same.

Most of all, you want to do it in a place where you’re more than an employee number.

A place you love working.

Still here?

Good.

Because if this is you, we’d really like to meet you.

What you will be doing: Trial and site administration: 1) Tracking (e.G.

essential documents) and reporting, 2) Ensure collation and distribution of study tools and documents 3) Update clinical trial databases (CTMS) 4) Responsible for clinical supply & non-clinical supply management Document management: 1) Prepare documents and correspondence 2) Collate, distribute, and archive clinical documents (i.E.

TMF) 3) Updating manuals/documents (e.G., patient diaries, instructions) 4) Document proper destruction of clinical supplies.

Regulatory & Site Start-Up responsibilities: 1) Provide to and collect from investigators forms/lists for site evaluation/validation and site start-up 2) Preparation of submission package for IRB/ERC and support regulatory agencies submissions.

Budgeting: Collaborate with finance/budgeting representatives for: 1) tracking, and reporting of negotiations 2) contract development, approval and maintenance 3) payments (investigators, vendors, grants 4) Monitor and track adherence and disclosures 5) Budget closeout Meeting Planning: 1) Organize meetings (create & track study memos/letters)2) Support local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)3) Contributes to strongly to CTC team knowledge by acting as process Subject Matter Expert, sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required (senior level) 4) Mentors/buddies junior CTCs on process requirements (Senior level) What You Will Need: BS/BA degree or equivilant experience Minimum of 2 yrs of related experience for Clinical Trial Coordinator level Minimum 3-5 yrs of related experience for Senior Clinical Trial Coordinator level Experience with PC-Windows, word processing, and electronic spreadsheets required.

Knowledge of ICH and local regulatory authority drug research and development regulations required.

Clinical trials support or pharmaceutical industry experience required.

Experience leading a team in a clinical research environment preferred.

Experience leading a team on global clinical trials preferred.

To qualify, applicants must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans, and individuals with disabilities.