Clinical Research Associate Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
ZELTIQ's first commercial product, the CoolSculpting System, is designed to selectively reduce stubborn fat that may not respond to diet or exercise. CoolSculpting is based on the scientific principle that fat cells are more sensitive to cold than the overlying skin and surrounding tissues. It utilizes patented technology of precisely controlled cooling to reduce the temperature of fat cells in the treated area, which is intended to cause fat cell elimination through a natural biological process known as apoptosis. Zeltiq developed CoolSculpting to safely, noticeably and measurably reduce the fat layer. Zeltiq is an equal opportunity employer.
Coordinates clinical research activities for Clinical Affairs
Essential Duties and Responsibilities include the following (other duties may be assigned.):
? Sets up and maintains central files for all clinical projects/studies in a consistent, neat, orderly and timely fashion
? Sets up and maintains files for case report forms generated by all clinical investigators
? Conducts in-house audits of case report forms prior to site monitoring visits and tracks corrections after monitoring has been performed
? Files correspondence in relevant site folders on a weekly basis
? Prepares and tracks IRB submissions, continuing reviews and annual reports for sponsored research
? Tracks site invoices and subject compensation for clinical research sites
? Coordinates tracking of site contract renewals for all clinical study sites
? Maintains database/tracking system for Clinical Affairs Department Operating Procedures (DOPs); maintains master/duplicate copies of all DOPs in hard copy and maintains current DOP directory on clinical shared drive
? Performs data entry function for clinical studies
? Performs study coordinator function for in-house device fit studies.
? Assists Clinical Research Associates with preparation/shipping of site correspondence, case report form and regulatory binders, clinical trial supplies, etc.
? Assists department members with compilation and/or preparation of Word/Excel/Power Point documents
? Assists department members with travel and meeting arrangements as needed
? Assists department members with mailing, shipment, ad photocopying as needed
? Maintains departmental calendar for internal visibility
? High School diploma required. 2 years college education is preferred.
? An ability to work independently as well as with a team, excellent organizational, communication and interpersonal skills are required
? Strong verbal and written communication skills.
? Must be a strong team player with the demonstrated abilities and willingness to wear ?multiple hats? and perform a wide range of tasks within a dynamic environment.
? Proficiency with MS-Office software including MS Word, Excel and Powerpoint. Proficiency with MS Access a plus.
? Responsible for performing all duties in compliance with FDA?s Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.
||Pleasanton, CA |
THIS JOB HAS EXPIRED