Senior Clinical Research Associate

This is a fully remote position, open to applicants in California, +3 more states.

📋 Description

• Act as the Clinical Research Associate (CRA) for designated complex clinical trials, overseeing site selection, initiation, monitoring, and close-out activities.

• Engage in site feasibility evaluations and the site selection process.

• Ensure that the conduct of the study adheres to clinical protocols, regulatory standards, IRB/EC requirements, and company standard operating procedures (SOPs).

• Prioritize patient safety, ensuring informed consent and study procedures are executed accurately and ethically.

• Review and report adverse events (AEs), serious adverse events (SAEs), and protocol deviations.

• Maintain thorough, accurate, and audit-ready regulatory documentation and Trial Master Files (TMFs) in line with ALCOA principles.

• Oversee the inventory of investigational products and study supplies.

• Identify, communicate, and manage potential study risks and issues.

• Author, review, and approve Monitoring Plans, source documents, monitoring tools, and training materials for site personnel.

• Conduct Source Data Review (SDR) and Source Data Verification (SDV), documenting monitoring activities through timely trip reports.

• Provide mentoring, training, and functional oversight to CRAs, including contingent CRAs.

• Lead or review functional job aids and training resources.

• Present study updates regarding site status, risks, and issues to both functional and study teams.

• Ensure accurate study data is maintained in Veeva Vault CTMS and CDMS.

• Collaborate with internal teams and Contract Research Organizations (CROs) to guarantee high-quality study execution and supervision.

• Develop and sustain relationships with investigator sites and internal stakeholders.

⛳️ Requirements

• Bachelor’s degree or higher in a healthcare or science-related discipline; alternative educational backgrounds may be considered based on experience and business needs.

• A minimum of 3 years of field-based CRA experience within the medical device and/or pharmaceutical sectors.

• Strong comprehension of clinical trial operations, monitoring practices, investigational product management, and data management.

• In-depth knowledge of both domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA.

• Exceptional written and verbal communication skills, including familiarity with medical terminology.

• Strong abilities in presentation, organization, time management, and prioritization.

• Technologically adept, with the capability to utilize technology for enhanced efficiency and performance.

• Ability to work autonomously with minimal oversight in a dynamic environment.

• Experience with In Vitro Diagnostic (IVD) and/or Point of Care (POC) studies is preferred.

• Laboratory experience in molecular biology, microbiology, or blood culture is preferred.

• Proficiency with Veeva Vault CTMS and CDMS is preferred.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for rewards and recognition.

• Competitive salary and benefits packages.

• Opportunities for learning, growth, and professional development.

• In-person collaboration that supports learning, progress, and success.