Clinical Research Associate Zeltiq Aesthetics, Inc.
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 |