Premier Research
biotech, medtech, and specialty pharma
ClinicalResearchAssociate(Canada)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Research Associate (Canada) at Premier Research. Skills: monitoring reports, data integrity, subject safety, site visits, trial issues, ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, drug/device development, clinical monitoring procedures, clinical/health systems, cultural/professional practices. Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines. Responsible for the validity, correctnes”
What You'll Achieve.
transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics; deliver the medical innovation that patients are desperate for
Industry & Context.
Travel up to 70-85%, Fluency in French is required
What They're Looking For.
Must Have
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited a licensed health-care professional (i. e. , registered nurse); or equivalent work experience required, Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures, Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where site monitoring activities will be conducted, Ability to multitask and work effectively with technology and people in a fast-paced environment with changing priorities, self-starter, Fluency in French is required
Nice to Have
Patient facing, study coordinating experience preferred
What You'll Do.
timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines
Responsible for the validity
and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155
protocol and client requirements
on site or other approved mode of monitoring) with a focus on data integrity and subject safety in accordance with local/regional laws and country specific regulations
Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
Prepares for and conducts on site and/or remote qualification
and close out monitoring visits as directed per CMP
Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
How You'll Work.
Team & Collaboration
Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase
Process & Methodology
Plans day-to-day activities for monitoring of a clinical study and sets priorities per site
Full Job Description
Premier Research is looking for a Clinical Research Associate I (Canada) to join our Global Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. * We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. * Your ideas influence the way we work, and your voice matters here. * As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. **What You 'll Be Doing:** * Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines * Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements * Monitors (remote, on site or other approved mode of monitoring) with a focus on data integrity and subject safety in accordance with local/regional laws and country specific regulations * Plans day-to-day activities for monitoring of a clinical study and sets priorities per site * Prepares for and conducts on site and/or remote qualification, study initiation, interim monitoring, dosing observation, and close out monitoring visits as directed per CMP * Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase **What We Are Searching For:** * Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience requi
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