Clinical Research Associate Zeltiq Aesthetics, Inc.
THIS JOB HAS EXPIRED Description
Responsible for coordination and management of all aspects of clinical study studies, including regulatory compliance, documentation requirements, monitoring, and close-out.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
? Maintains frequent contact with clinical site staff, preparing and tracking required documentation and assuring regulatory compliance with corporate SOPs as well as FDA and ICH guidelines.
? Develops and maintain clinical data summaries and analyses and present data for inclusion in regulatory submissions and/or other company uses.
? Develops clinical study documentation, including study protocols, investigator brochures, informed consent forms, case report forms, clinical study reports, annual reports, various study materials, and monitoring tools.
? Maintains site files. Prepare and conduct initiation visits, interim visits and termination visits.
? Tracks patient recruitment, produce status reports and monitoring reports, track SAEs, conduct study close-out activities, conduct query resolution, and other duties associated with monitoring and managing clinical studies.
? Aids in setting the strategy, budget, and goals for the clinical department.
? Provide training for company and clinical site staff through formal presentations.
? Stays up-to-date and follow all procedures related to this job that can affect the quality of products or services provided to our customers.
? BS/BA plus two years experience in clinical research studies.
? Minimum 2 years CRA experience highly desired.
? Proven track record of successful clinical study management.
? Ability to focus on and achieve scheduled milestones, including contingency planning.
? Good clinical knowledge with an understanding of medical terminology.
? Knowledge and understanding of ICH GCP guidelines and FDA regulations related to clinical studies.
? Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
? Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
? Ability to work with mathematical concepts such as probability and statistical inference.
? Ability to use MS Excel to perform calculations and interpret results/data.
? 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