Senior Clinical Research Associate (CRA)

Role Summary

Hands-on, detail-driven clinical research professional who thrives on collaboration and purpose. As a Senior Clinical Research Associate (CRA), you’ll serve as the key link between clinical sites and the Candel team—ensuring studies run with precision, integrity, and patient-centered care. You’ll oversee site readiness, patient recruitment, on-site and remote monitoring, and study close-out across multiple oncology programs, while fostering trust-based relationships with investigators and coordinators. This remote role is based on East Coast or Midwest time zones for convenient collaboration.

Responsibilities

• Be the bridge between sites and Candel. Act as the primary liaison for all site communications ensuring alignment, transparency, and timely updates between investigators, study staff, and internal teams.
• Lead site operations end-to-end. Conduct pre-study assessments, initiation visits, on-site and remote monitoring, and study close-outs in full compliance with GCP, SOPs, and FDA regulations.
• Champion quality and compliance. Verify that data are accurate, complete, and protocol-adherent; ensure all essential documents and training records are current and audit-ready.
• Drive patient recruitment and retention. Collaborate with sites to develop tailored recruitment strategies and maintain strong participant engagement.
• Monitor data flow and timelines. Track data entry, query resolution, biospecimen and bioimaging submissions, and safety reporting—proactively resolving issues before they impact deliverables.
• Partner with CTMs for continuous improvement. Support CAPA implementation for QA findings and contribute insights that strengthen future study execution.
• Manage site-level operations. Oversee cost tracking, coordinate payments, and maintain accurate documentation throughout the study lifecycle.
• Collaborate cross-functionally. Work with internal stakeholders to refine study tools, SOPs, and Case Report Forms (CRFs), helping shape best practices that raise the bar for operational excellence.

Qualifications

• Required: Bachelor’s degree; Master’s preferred in a health-related discipline.
• Required: 3+ years of experience in oncology clinical trials with strong command of GCP, FDA regulations, and industry best practices.
• Required: Proven ability to manage multiple studies and databases independently while maintaining high standards of accuracy and efficiency.
• Required: Excellent communication, organizational, and relationship-building skills—able to influence without authority and navigate complex site dynamics.
• Required: Strong technical proficiency with Microsoft Office and familiarity with common project management tools.
• Required: Sound judgment, professionalism, and discretion when handling sensitive or confidential information.

Skills

• Clinical monitoring and site management
• Data management and quality assurance
• GCP, FDA regulations, and regulatory knowledge
• Study coordination and cross-functional collaboration
• Communication and relationship-building
• Microsoft Office and project management tools
• CAPA understanding and issue resolution

Education

• Required: Bachelor’s degree; Preferred: Master’s degree in a health-related discipline