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Senior Clinical Research Associate

🕒 yesterday
Clinical ResearchOnsite Clinical Trial MonitoringCRF ReviewSource Document Verification
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📜 Description

  • Conduct and report SIV, RMV, and COV onsite monitoring visits.
  • Review CRFs and source documents, verify data, and resolve queries.
  • Manage site communications and serve as a contact for in-house support services and vendors.
  • Communicate study progress to internal project teams and participate in feasibility research.
  • Support regulatory document preparation for study submissions.
  • Prepare for and participate in audits and inspections.

🛠️ Requirements

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience
  • Experience in all types of monitoring visits in Phase II and/or III
  • Full working proficiency in English.
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel
  • Valid driver’s license
Full job description

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do.  A dynamic, global, mid-size company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals.  We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

    Job Description

    We are looking for an experienced freelance Sr. CRA to support us with the following responsibilities in Canada:

    • Conduct and report SIV, RMV, COV onsite monitoring visits
    • Perform CRF review, source document verification and query resolution
    • Be responsible for site communication and management
    • Be a point of contact for in-house support services and vendors
    • Communicate with internal project teams regarding study progress
    • Participate in feasibility research
    • Support regulatory team in preparing documents for study submissions
    • Prepare and particiapte on audits and inspections

    Qualifications

    • College/University degree in Life Sciences or an equivalent combination of education, training & experience
    • Independent on-site monitoring experience
    • Experience in all types of monitoring visits in Phase II and/or III
    • Experience in Oncology is a plus
    • Full working proficiency in English.
    • Proficiency in MS Office applications
    • Ability to plan, multitask and work in a dynamic team environment
    • Communication, collaboration, and problem-solving skills
    • Ability to travel
    • Valid driver’s license

    Additional Information

    For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.

    This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

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