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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
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| 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
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| City |
Any |
| Country |
Canada [CA] |
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