Principal Clinical Research Associate

📋 Description

• Act as the Lead CRA for designated complex clinical studies, offering expert guidance on site selection, initiation, monitoring, and close-out activities.

• Engage actively in site feasibility assessments and the selection process for sites.

• Ensure that the execution of study conduct adheres to the clinical protocol, regulatory standards, IRB/EC requirements, and company SOPs.

• Prioritize patient safety by ensuring that informed consent and study procedures are carried out accurately and ethically.

• Review and report Adverse Events (AEs), Serious Adverse Events (SAEs), and protocol deviations in line with regulatory and company guidelines.

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

• Oversee the 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 training materials for sites.

• Carry out Source Data Review (SDR) and Source Data Verification (SDV) in accordance with monitoring plans, documenting monitoring activities through timely, high-quality trip reports.

• Assist in interviewing, hiring, onboarding, and training CRA staff.

• Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues.

⛳️ Requirements

• A Bachelor’s degree or higher in a healthcare or science-related discipline.

• At least five (5) years of field-based CRA experience within the medical device and/or pharmaceutical sectors.

• Experience across multiple phases of clinical research and product development.

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

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

• Proficiency in Veeva Vault CTMS and CDMS is required.

• Excellent written and verbal communication skills in English, including familiarity with medical terminology.

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

• Technologically adept with the ability to utilize technology to enhance efficiency and performance.

• Capability to work independently with minimal supervision in a fast-paced environment.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Competitive compensation and benefits package.