Principal Clinical Research Associate (In-House Principal CRA) Elixir Medical - 2.9 Milpitas, CA Job Details $125,000 - $135,000 a year 19 hours ago Benefits Continuing education credits Qualifications Microsoft Excel ICH guidelines Biomedical regulatory compliance Productivity software Medical terminology Full Job Description Major Duties and Responsibilities Responsibilities will include, but not be limited to: Develops site and study documentation such as training materials, protocols, plans, tracking reports, study manuals, and regulatory submissions for clinical research studies In-house monitoring to study and procedure instructions of CRF's and study regulatory files Support Clinical staff for audit readiness and preparations Review study processes and documentation for GDP, GCP, and regulatory compliance Maintains documentation of all clinical research activities, e.g. site communications, correspondence, inventory information, etc. Duties include electronic and/or hardcopy file maintenance Monitor and tracks site and subject enrollment, track milestones and manage trial invoices Prepares study site and in-house materials and meeting arrangements for study and site initiations, investigator meetings and other study meetings Prepares and provides materials for vendor/contractor training, including meeting arrangements, conduct and documentation Supports Inventory Administration including all documentation for shipping, receiving and returned goods Supports data management activities in CRF development, validation and verification rules and other reporting/analysis activities, reimbursement for sites and preparation of CEC and DMSB materials Manages other In-House CRAs or provides mentorship, as assigned Supports department activities as required Qualifications Experience 7+ years in the role of Clinical Research Associate supporting Clinical trials of all phases, medical device trial experience strongly preferred Ability to be primary / lead in-house clinical contact for a project Working knowledge of Medical Terminology, FDA and MDR regulations, and ICH GCP guidelines Working auditing and self-auditing skills Excellent verbal and written communication skills Ability to handle multiple tasks with competing priorities Proficiency with Microsoft Office suite of applications (Word, Excel and PowerPoint) Prior experience with Electronic Data Capture (EDC) systems Minimal Travel to headquarters on an ad-hoc basis Education Requirements Bachelor's degree or higher in a life sciences discipline preferred CCRA preferred The salary range is $125K to $135K based on factors including geographic location, experience, skills, etc.