Job Description :
CRA II
6+ Months
Pleasanton, CA
Job duties include but not limited to the following:
· Plans, implements and executes FDA registration studies to support clinical claims.
· Supports the preparation of reports and summary documents (for internal and external customers) for product registration.
· Assists team in budget and contract negotiations with study sites, central laboratories and CROs. Monitors adherence to the study budgets and timelines.
· Conducts study start-up, monitoring and study close-out visits.
· Ensures adherence to regulations, guidelines and departmental standard operating procedures.
· Plans and prepares execution of studies through all phases of the study process
· Provides technical input to study designs and clinical development plans
· Reviews study protocols, reports and manuscripts
· Works with Data Management and Biometrics staff on the design of documents and processes for the collection of study data from participating sites
· Ensures study site compliance with Good Clinical Practices, regulations, SOPs and protocols.
· Collects and maintains legal and regulatory documentation, as applicable
· Ensures accurate and complete study management/data collection and transfer into the data management system
· Acquires and maintains technical knowledge of product line
Requirements:
· 3-5 years of CRA experience
· IVD experience is preferred
· Microbiology clinical trial experience highly desirable
· Laboratory/Med Tech background highly desirable
· Bachelor''s or Masters in Biology, Chemistry, Molecular Biology or related discipline.
· Extremely detail oriented.
· Ability to work in a team situation
· Vendor management experience
· Budget and contract development
· Ability to solve problems in a detailed, comprehensive manner with demonstrated urgency and energy to handle problems.
· Must meet timelines and manage sites.
· Excellent written and verbal communication skills and good presentation skills are required.
· Experience developing professional presentations and presenting to investigational sites and management
· MSWord, Excel and PowerPoint skills are required.
· Up to 35% travel (primarily domestic