Principal Clinical Research Associate (In-House Principal CRA)

#### 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.