Associate - Clinical Research
Job Requisition #: 11408
Date Posted: 08/10/2011
Category: Clinical
Location: Cardio-Plymouth - MN - USA
About Us
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
We are an Equal Opportunity/Affirmative Action Employer. We currently have the following opening in our Cardiovascular Division:
Job Overview
Summary: Designs, implements, monitors and closes out clinical investigations. Support professionalism and scientific expertise of department.
Duties and 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.
Physical Requirements:
Frequent computer monitor and keyboard use.
Sitting for long periods of time.
Education, Experience, Personal and Technical Skill:
BA/BS in business, medical science or nursing (or equivalent experience).
2 - 4 years experience in clinical research, preferably with a medical device company.
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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