The Clinical Research Associate (CRA) assists in monitoring and completion of high quality, Class III medical device clinical trials. This position will be a primary contact with medical professionals involved in clinical studies. Must be enthusiastic, positive and even tempered. Must be effective in building interpersonal, working relationships with various clinical personnel. Experience should demonstrate dependability, flexibility and maturity. Must be able to travel at least 20% of the time.
- Coordinate setting up of study centers.
- Assist in development of relevant clinical SOPs.
- Assist in the preparation and distribution of training materials.
- Assist in conducting investigator meetings.
- Provide support to clinical investigators/coordinators to resolve site related issues.
- Manage device accountability and distribution to clinical centers.
- Monitor and visit clinical trial sites to ensure conformance with study protocol.
- Prepare site visit reports.
- Track, collect and review clinical documentation.
- Review and report adverse events in conformance with FDA regulations.
- Coordinate with clinical investigators in the timely completion, submission and review of CRFs and verify report data against protocol and patient files.
- Identify and gather missing or incomplete data from CRFs.
- Assist in preparing information for statistical analysis.
- Assist in tracking, filing and report preparation of clinical data.
- Assist in the review and preparation of data and documents for PMA application.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin.
- BS degree in health/science related field.
- Minimum of 4 years experience in clinical/scientific research, nursing or relevant work in medical device or pharmaceutical industry.
- Minimum of 2 years experience in clinical monitoring. Experience with spinal devices is a plus.
- Excellent verbal, written and organizational skills.
- Good computer skills.
- Must be detail oriented.
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