Full-Time

Clinical Research Associate

Clinical Research Associates

Alimentiv

Alimentiv

No salary listed

London, ON, Canada

Remote

Category
Biology & Biotech (2)
,
Required Skills
Google Cloud Platform
Requirements
  • CRA I - minimum 1 year experience + Honours Bachelor Degree
  • CRA II - Minimum 2 years experience + Honours Bachelor Degree
  • Sr. Clinical Research Associate - Minimum 3 years experience + Honours Bachelor Degree
Responsibilities
  • Support/conduct site management through remote and supervised onsite visits (initiation, monitoring, and close-out) in compliance with SOPs, protocol, and GCP.
  • Perform remote data and system reviews (EDC, CTMS, RBM, TMF) to ensure data quality, completeness, and regulatory compliance.
  • Assist/lead (as appropriate) with query resolution, safety reviews, and adverse event follow-up throughout the study lifecycle.
  • Support/conduct (as appropriate) site startup and activation activities, including investigator coordination, trial material delivery, and recruitment support.
  • Maintain accurate, timely, and complete TMF documentation, requesting updates as required.
  • Provide day-to-day operational support to Senior CRA, and Lead CRAs.
  • Participate in training, study meetings, and CRA development activities, building competencies required for role progression.
  • Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.
  • Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.
  • When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.
  • May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.
  • May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.
  • Oversee overall integrity of the study to promote positive working relationships with the site and staff.
  • Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.

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