Clinical Research Specialist Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
Essential Duties and Responsibilities include the following (other duties may be assigned):
Ensure a friendly and orderly environment that fosters clinical research activities that conform to GCP and CFR.
Responsible for the overall operation of clinical research activities, including patient recruitment, preparation of study-related paperwork (such as source documentation), completion of CRFs, maintenance of study regulatory files, site-required IRB activities, as well as provide treatment assistance.
Manage study subjects to ensure compliance of the study requirement.
Perform image documentation such as photographs, ultrasound and/or other images.
Provide reception for clinic patients and ensure smooth patient flow through clinic.
Other Clinical Affairs Activity
Data entry and validation.
Assist in preparation of study related materials.
Assist in preparation of study reports.
Perform other related duties as assigned.
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 requirement with which ZELTIQ complies.
BS/BA in a field relevant to the biomedical device industry (such as Nursing, Biological Sciences) or BS/BA with equivalent work experience.
One year relevant clinical research experience such as working in a research clinic, is highly preferred.
Demonstrate a strong customer-oriented attitude. Able to establish rapport and put study participants at ease.
Excellent interpersonal, oral and written communication skills.
Proficient with MS Office, including Word and Excel.
Occasional flexibility in work hours, including weekends, may be required.
Working knowledge of medical terminology
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