Senior Clinical Research Associate

ClinForce is currently seeking a Senior Clinical Research Associate in Alameda, CA.
Successful candidate will design, implement and monitor regional clinical studies of new and modified products and competitive products. The CRA also ensures that the clinical studies of products are designed to validate product performance claims and support the products' intended use, prepares clinical data reviews and data summaries, provides customer support directly to health care professionals and hospitals as well as, scientific support in the resolution or product issues and promotion of products and manages a single large project, a more complex project or several smaller related projects. Major responsibilities are as follows:
Knowledge of regulations and standards affecting IVDs
Complies with all policies, established procedures and regulations related to clinical research
Participates in assessing performance data generated by R&D prior to initiation of the clinical study
Acquired a basic understanding of principles of the assay and/or instrument and hands-on knowledge and skills in performing assigned assays or operating instruments
Prepares clinical protocol, instructions for use, case report forms, informed consents and other required documents for clinical studies
Identifies and qualifies clinical investigators and clinical sites
Proposes and negotiates budgets for clinical studies
Obtains and reviews all required essential documents necessary for study initiation
Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH.GCP guidelines; assuring subject rights, safety and welfare are protected, data integrity through completeness, accuracy and legibility
Reviews data, prepares and presents clinical data reviews and data summaries
Responds to audits and data queries
Assists in preparation of the clinical sections of regulatory submissions and international registration packages
Initiates publication or presentation of clinical data in professional journals or meetings
Provides clinical and technical support to Sales and Marketing and interacts with all levels or medical and scientific professionals
Advises and trains newly hired CRAs
Suggests improvements for increased departmental efficiency
REQUIREMENTS
3-5 years experience
BA/BS Degree