Sr. Clinical Research Associate - Regional
Job Requisition #: 11541
Date Posted: 08/24/2011
Category: Clinical
Location: Central - Region - 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 our Cardiovascular Division:
Job Overview
The Sr CRA Regional will conduct site initiation visits, monitor clinical data for multiple studies, and conduct close-out visits. Supports professionalism and scientific expertise of the department.
Responsibilities:
• Follows department Standard Operating Procedures.
• Monitors clinical investigations for multiple studies and sites simultaneously, to
a. Assure protocol compliance per applicable regulations;
b. Assure subject rights, safety and welfare are protected;
c. Assure data integrity through completeness, accuracy, legibility and logicalness.
• Completes monitoring reports and follows open action items in a timely basis.
• Assists Clinical Research Associate in setting 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 in organizing Investigator and Data Safety Monitoring Board meetings.
• Conducts monitoring visits to assure protocol compliance and data integrity.
• Generates presentations when requested by investigators or AGA personnel.
• Generates status reports and sends to investigators on a regular basis.
• Assists Regulatory Affairs in preparation of safety, efficacy and performance inquiries.
• Acquires professional, product and market expertise via independent reading, networking and training.
• Travels approximately 85%.
• Participates in professional activities outside of normal business hours.
• Other duties as assigned.
Education, Experience, Personal and Technical Skills:
• BA/BS in business, medical science or nursing (or equivalent experience).
• 5-8 years experience in Clinical Research, preferably in a medical device company.
• 5 years monitoring experience, preferably in a field position.
• Strong ability to prioritize and organize multiple projects, simultaneously.
• 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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