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Title Clinical Research Associate II
Responsibilities • Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites for GCP compliance according to PharmaNet/i3 SOPs and/or client guidelines
• Generate study specific documentation including monitoring trip reports, telephone contact reports, site correspondence and expense reports
• Recruit investigators for participation in clinical trials
• Conduct project feasibility assessments
• Negotiate study budgets with investigators
• Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
• Review draft protocols for completeness and feasibility
• Develop Case Report Forms for clinical trials
• Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators’ Meetings
• Prepare and process Serious Adverse Event (SAE) reports, according to plan
• Prepare project management reports for clients, project personnel, and PharmaNet/i3 management
• Resolve queries of CRF data with study site personnel
• Review tables and listings generated from study data
• Assist in writing clinical study reports
• Train junior CRAs on monitoring, internal procedures, and query resolution

Requirements •Bachelor’s Degree or RN
•Must be fluent in French
•Candidates should be located in Eastern Canada
•Eighteen months experience in field monitoring for a pharmaceutical/biotech company or CRO
•Excellent written and verbal communication skills
•Ability and willingness to travel up to 80% of the time
•Excellent organizational skills
•Ability to manage time and work independently
City Any
Country Canada [CA]
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