Clinical Research Associate I/II (Quebec)

Montreal

Offre publiée le 2024-07-07

ICON Strategic Solutions

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.

ResponsibilitiesWhat you will be doing : Conduct clinical trial site visits including evaluation, initiation, monitoring and close outOversee and report on the conduct of clinical trials at a site level including and on-line site visit reports and updates to electronic management systemsProactive site management including : Building and maintaining solid and professional relationships with site staffFacilitating subject enrolment incorporating recruitment strategies and action plans at site levelMaintaining site audit / inspection readinessEnsuring appropriate safety reporting and use of on-line safety reporting / reviewing systems such as IntralinksVerification of electronic case report form data against written and electronic source documentation as per study schema / monitoring planResponding to site queries and escalating issues in accordance with processes and timelinesConducting IP accountability and reconciliationFacilitating implementation of new technologies and systems at clinical sites (Electronic Data Capture, eSAE reporting)Maintenance of site study supplies Operational Excellence : Contribute to sponsor goalsPromote operational and scientific excellenceIdentify opportunities and best practices with local / regional partners that will contribute to the overall operational effectiveness.

QualificationsYou are : BA / BS / BSc in the sciences or nursing equivalentA trained CRA with on-site monitoring experienceComprehensive knowledge and understanding of ICH-GCPFluent oral (face to face and telephone) and written English language skillsAble and willing to travel up to 60% of the time or as per local requirementsPossession of a full driver’s licenseAble and willing to work from a designated and appropriate home office as per local requirementsWilling to attend and contribute to team meetings including mandatory training (remote / off-site)Competent computer skills including working knowledge of common software packagesWorking knowledge of trial management databases and on-line systemsAble to attend a 1 week face to face in-house training course as part of on-boarding trainingAble and willing to work on several protocols / therapy areasExperience 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)

9 hours ago