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Organization Overview inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team. With 7,000 passionate employees in more than 36 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. inVentiv Health Clinical is part of inVentiv Health, a best-in-class team of global healthcare experts offering clinical, commercial and consulting services designed to provide a comprehensive customer experience that delivers greater long term value.
Title Sr. Clinical Research Associate
Job ID 5787
Position Overview We currently have an opening for a Clinical Research Associate located in Alberta or British Columbia, Canada. The Clinical Research Associate performs activities associated with the site-level feasibility, evaluation, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites in the geographic area assigned to them.
Responsibilities • Completes site-level feasibility tools/questionnaires
• Develops monitoring plan
• Conducts clinical site visit reports
• Generates list(s) of qualified sites following feasibility conduct (shared deliverable)
• Creates/contributes to site specific patient recruitment and retention plans (shared deliverable)
• Performs collection of high-quality clinical trial data (CRFs)
• Conducts query resolution
• Employs corrective and preventative action responses to monitoring-related observations on audits and inspections
• Strategizes plan for territory development (shared deliverable)
• Responds to requests for site level study and/or territory information
Requirements • Bachelor’s degree
• 4+ years clinical study site monitoring experience
• 3+ years work experience in life science or medically related field including one (1) year clinical research experience (eg, study coordinator)
• Experience working on Ophthalmology trials strongly desired
• Previous experience as a Regional CRA in the biopharmaceutical industry
• Ability to travel
• Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Good understanding of clinical study budgeting and the drug development process
• Knowledge of concepts of clinical research and drug development
• General therapeutic area education and training
• Excellent communication skills
• Excellent decision making skills
• Excellent interpersonal skills
• Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
• Self-starter with ability to work independently in a regional area with remote or minimal supervision
• Ability to work effectively in a team/matrix environment
• Ability to influence others without direct reporting relationships
• Ability to understand technical, scientific and medical information
City Vancouver
Country Canada [CA]
State/Province British Columbia [BC]
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