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Regional clinical research associate

Inventiv Health

This is a Full-time position in Montreal, QC posted May 14, 2019.

Title of Position: Senior Regional Clinical Research Associate Location: Home-based in Quebec, preferably Montreal area Permanent Salaried opportunity Requirements: 
• 4 year degree
• Must have minimum 2 years of onsite monitoring experience from CRO or Pharma.

Must be French speaking : Responsible for providing site management and support to external trial staff (Principal Investigators and Study Coordinators) from trial initiation to closeoutEnsure collection of high quality data, timely adverse event reporting, subject protection and compliance to the protocolAdherence to ICH-GCP, Canadian regulatory requirements, local ethics requirements, SOPs, and Clinical Development GuidelinesManage recruitment and retention strategies at the site level, analyzing enrollment and randomization projections against actual recruitment numbers to ensure targets are metCollaborates regularly with Local Trial Manager (LTM) and Line of Business Manager, communicating site progress and escalating critical issues that could impact trial milestonesTrains and supports external trial staff regarding requirements for CRF and IVRS data entry, AE/SAE/MESI reporting, ethics reporting, protocol deviation identification, drug accountability and temperature monitoring, query resolution, essential document collection and ITF filingIdentifies objectives for scheduled monitoring visits; ensures planned visit objectives are achieved to meet protocol and SOP timelines.Prepares and completes monitoring visit reports and follow up letters within the timeline established by the applicable SOPs and guidelines Completes system training (IMPACT, IV/WRS, EDC, CATS, CONCUR etc.) in order to adhere to protocol and SOP timelines to meet required deliverables.Proactive use of EDC and other data source systems for preparation and conduct of site visits as well as source data verification in collaboration with data management/logistics teamIdentify potential risks and proactively take action to prevent or mitigateParticipates in Sponsor and Regulatory audits in Canada; preparing external trial staff and site records, addressing questions from Auditor, supporting external trial staff during audit, preparing audit responses ensuring compliance to local guidelines, SOPs and ICH-GCP.

Company The coming together of INC Research and inVentiv Health as one global company, called Syneos HealthTM, has created the industry’s only true end-to-end solution.

This one entity combines world-renowned clinical research and commercialization capabilities with today’s most advanced science, business and data technologies to make real advances possible.

We help you improve performance, reduce risk and expedite delivery of healthcare innovation to patients worldwide.