Principal Clinical Research Associate

This is a fully remote position, open to applicants in Maryland.

📋 Description

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

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

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

• Prioritize patient safety by ensuring informed consent and adherence to study procedures are executed accurately and ethically.

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

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

• Oversee site inventory of investigational products and study materials.

• 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.

• Conduct Source Data Review (SDR) and Source Data Verification (SDV) as per monitoring plans and document monitoring activities with timely, high-quality trip reports.

• Assist in the interviewing, hiring, onboarding, and training of CRA personnel.

• Present confidently and contribute to extended functional and study team meetings, offering 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 spanning multiple phases of clinical research and product development.

• Strong preference for experience with In Vitro Diagnostics (IVD) and/or Point of Care (POC) studies.

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

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

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

• Required proficiency with Veeva Vault CTMS and CDMS.

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

• Strong presentation, organizational, time-management, and prioritization abilities.

• Technologically adept with the capacity to leverage technology for improved efficiency and performance.

• Capable of working independently with minimal supervision in a fast-paced environment.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Competitive compensation and benefits package.