Perm Sponsor Bilingual Canadian CRA

Category: CRA
Job #: 10899
Utilization: Perm
Location: Anywhere Canada, Montreal preferred
Job Type: Perm
Therapeutics: Cardiology and Device

We have a medium-sized Sponsor who is looking for a Perm CRA to join their team. Qualified candidates will be bilingual, thus fluent in both English and French.

Only Canadians will be considered, with the favored location being in the east, as the majority of the sites are in Ontario and Quebec. The position requirements are below.

Job Responsibilities:
  • Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
  • Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
  • Develop and implement site recruitment, selection and initiation plan.
  • Manage and drive patient recruitment and enrollment tracking.
  • Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
  • Ensure essential document collection for completeness per regulatory requirements.
  • Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
  • Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
    Manage one or multiple studies.
  • Monitor product supplies/accountability including proper storage, dispensation, and disposal.
  • Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
  • Review in-house data and study tables.
  • Mentor, coach and provide guidance to clinical staff as appropriate.
  • Supervise and train other employees as appropriate.
Job Qualifications:
  • Must be located in Canada, preferably in Quebec or Ontario, and be fluent in both English and French.
  • Minimum 5 years’ recent experience as a CRA for a Sponsor or CRO
  • Experience monitoring Surgical / In-Patient studies
  • Experience monitoring Device studies
  • Experience within the Cardiovascular therapeutic (as a nurse or a monitor)
  • Must have experience in Study Start-up and Risk-Based Monitoring
  • A bachelor's degree and the COVID-19 vaccine are required
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