Clinical Research Associate I/II

3 days ago

Alberta, Canada ICON Strategic Solutions Full time

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development as a Clinical Research Associate II.


Responsibilities

What you will be doing:

  • Conduct clinical trial site visits including evaluation, initiation, monitoring and close out
  • Oversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systems
  • Proactive site management including:
  • Building and maintaining solid and professional relationships with site staff
  • Facilitating subject enrolment incorporating recruitment strategies and action plans at site level
  • Maintaining site audit/inspection readiness
  • Ensuring appropriate safety reporting and use of on-line safety reporting/reviewing systems such as Intralinks
  • Verification of electronic case report form data against written and electronic source documentation as per study schema/monitoring plan
  • Responding to site queries and escalating issues in accordance with processes and timelines
  • Conducting IP accountability and reconciliation
  • Facilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)
  • Maintenance of site study supplies

Operational Excellence:

  • Contribute to sponsor goals
  • Promote operational and scientific excellence
  • Identify opportunities and best practices with local/regional partners that will contribute to the overall operational effectiveness.


Qualifications

You are:

  • BA/BS/BSc in the sciences or nursing equivalent
  • A trained CRA with on-site monitoring experience
  • Comprehensive knowledge and understanding of ICH-GCP
  • Fluent oral (face to face and telephone) and written English language skills
  • Able and willing to travel up to 60% of the time or as per local requirements
  • Possession of a full driver’s license
  • Able and willing to work from a designated and appropriate home office as per local requirements
  • Willing to attend and contribute to team meetings including mandatory training (remote/off-site)
  • Competent computer skills including working knowledge of common software packages
  • Working knowledge of trial management databases and on-line systems
  • Able to attend a 1 week face to face in-house training course as part of on-boarding training
  • Able and willing to work on several protocols/therapy areas
  • Experience in phase II and phase III trials (preferred)
  • Working knowledge of Electronic Data Capture (preferred)
  • Experience/working knowledge of the oncology disease area (preferred)
  • Experience of Centralized/Risk Based/Targeted monitoring (preferred)
  • Experience of working within a metric based environment (preferred)

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