Principal Clinical Research Associate

Responsibilities

• Serve as Lead CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and close-out activities (on-site, virtual, remote, and in-house)
• Actively participate in site feasibility assessments and site selection processes
• Ensure study conduct is executed according to the clinical protocol (CPSP), regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs
• Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically
• Review and report AEs/SAEs and protocol deviations in accordance with regulatory and company requirements
• Maintain complete, accurate, and audit-ready regulatory documentation and TMFs in accordance with ALCOA principles
• Monitor site inventory of investigational products and study supplies
• Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance
• Author, review, and approve Monitoring Plans, study source documents, monitoring tools, and site-facing training materials
• Perform SDR/SDV per monitoring plans and document monitoring activities through timely, high-quality trip reports
• Ensure strict compliance with company travel and expense policies
• Provide mentoring, training, and functional oversight of CRAs, including contingent (contract) CRAs
• Lead or review functional job aids and training materials
• Support interviewing, hiring, onboarding, and training of CRA staff
• Manage and oversee day-to-day activities of contingent CRAs, including approval of timecards and expense reports
• Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues
• Utilize and maintain accurate study data in clinical systems, including Veeva Vault CTMS and CDMS
• Work cross-functionally with internal teams, CROs, and SMOs to ensure high-quality study execution and oversight
• Build and maintain effective working relationships with investigator sites and internal stakeholders

Requirements

• Bachelor’s degree or higher in a healthcare or science-related field
• Minimum of five (5) years of field-based CRA experience in the medical device and/or pharmaceutical industry
• Experience across multiple phases of clinical research and product development
• Experience with IVD and/or POC studies strongly preferred
• Laboratory experience in molecular biology, microbiology, or blood culture is highly desirable
• Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management
• Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA
• Proficiency with Veeva Vault CTMS and CDMS required
• Excellent written and verbal English communication skills, including medical terminology
• Strong presentation, organizational, time-management, and prioritization skills
• Technically savvy with the ability to leverage technology to drive efficiency and performance
• Ability to work independently with minimal supervision in a fast-paced environment
• ATS Optimization Keywords
• Hard Skills
• Clinical Protocol Execution
• Site Feasibility Assessment
• Adverse Event Reporting
• Regulatory Documentation Management
• Investigational Product Management
• Data Management
• Monitoring Plan Development
• SDR/SDV Execution
• Audit-Ready Documentation
• Laboratory Experience in Molecular Biology
• Soft Skills
• Excellent Written and Verbal Communication
• Strong Presentation Skills
• Organizational Skills
• Time Management
• Prioritization Skills
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