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    Project Specialist - Toronto, ON, Canada - Ozmosis Research Inc.

    Ozmosis Research Inc.
    Ozmosis Research Inc. Toronto, ON, Canada

    6 days ago

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    Description

    Job Title:
    Clinical Trials Specialist Hours: 35 HRS/week; 9:00-5:00, Monday-Friday


    Status:
    Full Time


    Level:
    Minimum 2 Years Experience

    Position:
    Combination in-office and remote position

    If you have experience in oncology, clinical trials management, project management and would appreciate the opportunity to work in a setting that moves clinical research forward, we would be interested in hearing from you.

    Ozmosis Research Inc. is an independent, entrepreneurial clinical trials management company in Canada operating as a social enterprise (not for profit).

    We are a trusted partner for biotechnology and pharmaceutical companies as well as academic institutions and investigators, and we have an impressive track record of success in clinical research.

    We provide our expertise to pharmaceutical and biotechnology companies to help them succeed with the design and implementation of their Phase I, II and III clinical trials.

    We offer services provided by traditional CRO's with a distinct advantage – our clinical research and oncology experience and our network of contacts at leading centres in Canada, US, and Europe.

    The Clinical Trials Specialist (CTS) participates in the development, coordination, data and project management of clinical trials from protocol development/review, approval through to activation, follow-up and trial closure.

    The CTS is responsible for a wide variety of projects involving phase I, II, and III trials for various investigator-initiated sponsors, pharmaceutical, and biotechnology companies.

    Project management
    Protocol development, writing, and amendments
    Regulatory compliance
    Site Management
    Communication with various stakeholders including sites, staff, and sponsors at all levels.
    Utilize quality assurance procedures to ensure that high quality data is obtained.

    Ensuring studies are conducted in accordance with ICH-GCP, Health Canada, FDA and US Federal Code, as well as other regulatory agencies.

    At minimum, completion of a Bachelor's of Science degree or recognized equivalent

    At least 2 years of experience in some or all of oncology, clinical trials management, project management, regulatory issues involving human subjects

    Skills & Functional/Technical Competencies
    Experience in project and site management
    Demonstrated proficiency in English grammar, with excellent oral and written communication skills
    Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines
    Demonstrated proficiency in MS Office Suite (Word, Excel and PowerPoint)
    Experience in Oncology and Medidata Rave an asset

    If you have experience in oncology, clinical trials management, project management and would appreciate the opportunity to work in a setting that moves clinical research forward, we would be interested in hearing from you.

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