Sr. Clinical Research Associate - Regional
Job Requisition #: 11541
Date Posted: 08/24/2011
Category: Clinical
Location: Central - Region - 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
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.
|E-mail this position
Submit Resume or C.V.
