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Position Title:
Department:
Reports To:
FLSA:
Survey Job Code:
Survey Job Title:
Summary:
Design, plan and conduct clinical research trials by effectively coordinating the activities of study coordinators and
investigators and by ensuring compliance with study protocols, FDA and International regulations, IRB and/or Ethics
committees requirements and overall clinical objectives.
Essential Duties and Responsibilities:
Under the direction of the Manager of Clinical Affairs, implement clinical research projects.
Review source documentation, case report forms, and data reports for accuracy and ensure the timely
submission of such documentation.
Identifies hazards and mitigating risk associated with identified hazards in Design and Process FMEA and
determining severity of the harms associated with identified hazards.
Evaluates product history data based on customer complaint records, results of controlled investigations and
published literature for the device or similar devices, if applicable.
30 to 50% travel.
Education, Training, Skills and Experience Requirements:
Minimum of 2 to 5 years experience with a Clinical trial experience with Medical Devices is preferred.
Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
Exercise good judgment within generally defined practices and policies in selecting methods and techniques for
obtaining solutions.
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Date