Clinical Research Associate II
Job Requisition #: 12425
Date Posted: 02/07/2012
Category: Clinical
Location: Plymouth - MN - USA
About Us
Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?
We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Plymouth.
Job Overview
The Clinical Research Associate II designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department.
Responsibilities:
• Follows department Standard Operating Procedures
• Sets up sites: clinical research agreements, IRB Approvals, etc
• Prepares and maintains in-service manuals, case report forms, informed consent and other specialized documents for clinical investigations
• Assists Regulatory in annual report and progress reports to the FDA
• Organizes Investigator and Data Safety Monitoring Board meetings
• Reviews data forms and DCF generation
• Conducts field audits to assure protocol compliance and data integrity
• Generates presentations when requested by investigators of AGA personnel
• Generates follow-up reminder reports and sends to investigators or AGA personnel
• Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries
• Acquires professional, product and market expertise via independent reading, networking and training
• Counsels and trains newly hired CRAs and monitors
• Travels approximately 20%
• Participates in professional activities outside of normal business hours
• Performs other related duties as requested
Requirements:
• BA/BS in business, science or nursing
• 2 - 4 years experience in clinical research including monitoring
• Ability to constructively interact with a range of personalities and range of positions, both inside and outside the organization
• Excellent written and verbal communication skills
• Ability to work independently and take direction from others
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