PRAHS

  • Clinical Trial Coordinator/Senior Clinical Trial Coordinator - Regulatory - Montreal

    Job Locations (All) | Canada-QC
    Posted Date 1 week ago(12/7/2018 1:50 PM)
    ID
    2018-50932
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it?

     

    Because we’re hoping you’re here for the latter.

     

    Who are we?

    We Are PRA.

     

    We are 15,000+ employees strong, operating in more than 85 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 forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be Clinical Trial Coordinator, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. 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.

    Responsibilities

    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

    5) Manage labeling requirements and coordinate/sign translation change request 

     

    Document management:

    1) Prepare documents and correspondence

    2) Collate, distribute, and archive clinical documents 

    3) Assist in TMF reconcilliation

    4) Updating manuals/documents (e.g., patient diaries, instructions)

    5) Document proper destruction of clinical supplies

    6) Prepare investigator trial file binders

    7) Execute eTMF Quality Control Plan 

    8) Obtain translations of documents

     

     

    Regulatory & Site Start-Up responsibilities: MAIN FOCUS

    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

    2) Support local investigator meetings

    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)

    Qualifications

    What You Will Need: 

    • BS/BA degree required 
    • Minimum of 2 years 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 the United States, 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.

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