Clinical Data Monitor
The position is responsible for performing monitoring activities associated with all ongoing Class III FDA-related clinical studies. This individual will need to perform site monitoring visits by adhering to the schedule established in Globus’ SOP’s to ensure the investigational sites are conducting the study according to the approved protocol and all applicable regulatory requirements. This person must be enthusiastic, positive, even-tempered and effective in building working relationships with various external consultants, clinical site personnel, and Globus Clinical Affairs and Regulatory staff. This individual must adhere to FDA 21 CFR regulations in all duties and must be able to travel up to 85% of the time to destinations across the United States.
· Schedule and perform monitoring visits for all clinical trials in accordance with established Globus SOP’s
· Perform thorough review of study-related information and files at each site visit (compliance with approved protocol, proper informed consent, compliance with inclusion/exclusion criteria, etc.)
· Help ensure proper documentation for and reporting of adverse events
· Document all findings for monitoring visits, maintain and update issue tracking log, write and distribute Monitoring Reports
· Work closely with clinical site personnel and members of the Globus Clinical Affairs department to ensure timely resolution to identified issues
· Promptly notify Globus Clinical management of any site negligence, non-compliance or severe protocol deviations
· Review clinical data for trends in missing or incorrect data relating to sites or investigators
· Assist with other tasks as assigned by the Clinical Affairs Group Manager
· Review, improve and train staff on relevant Clinical Affairs SOP’s as needed
· Experience performing clinical monitoring for IDE studies or studies involving medical devices (spinal device experience preferred)
· Must be detail-oriented
· Excellent verbal, written and organizational skills
· Ability to work effectively in a fast-paced, team-oriented environment
· Good computer skills
· BS degree in health science or related field
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.
Globus Medical - 19 months ago
If Globus Medical helps you stand up straight, then the company's products are working. Globus Medical makes medical devices used...