FSP Senior CRA I - U.S. Northeast Region - Multiple Therapies

Senior Clinical Research Associate I supporting pharmaceutical and biotech trials across the U.S. Northeast. Responsible for clinical monitoring, site management, protocol compliance assessment, and data integrity oversight for dedicated client accounts.

Responsibilities

• Monitor investigator sites using risk-based approaches and root cause analysis to ensure protocol compliance
• Conduct on-site and remote visits to assess regulatory compliance and manage essential trial documentation
• Ensure data accuracy through source document review, verification, and case report form review
• Document findings in timely reports and escalate deficiencies to clinical management for resolution
• Maintain regular contact with investigational sites and provide trial status updates to project leadership

Requirements

• Bachelor's degree in life sciences or Registered Nursing certification
• 3+ years of experience in clinical research or equivalent
• Strong ICH-GCP guidelines and regulatory compliance knowledge
• Proficiency with clinical trial management systems (CTMS) and monitoring platforms
• Excellent critical thinking, problem-solving, and communication skills
• Ability to travel over 75% for on-site monitoring activities

Compensation: $105,000–$112,000 base