FSP CRA I & CRA II - Oncology - Respiratory - Cardiovascular - Southeast region

Thermo Fisher Scientific seeks Clinical Research Associates (Level I & II) to conduct remote and on-site monitoring of clinical trials in respiratory and cardiovascular therapeutic areas across the Southeast region. The role involves ensuring protocol compliance, managing site documentation, and coordinating with investigational sites to maintain regulatory standards and data integrity.

Responsibilities

• Conduct remote and on-site visits to assess protocol compliance and regulatory adherence
• Manage clinical trial documentation and coordinate site management procedures across multiple sponsor environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, and applicable regulations to protect subject safety and data quality
• Develop and maintain collaborative relationships with investigational sites and facilitate audit readiness
• Apply risk-based monitoring concepts and perform root cause analysis for protocol deviations

Requirements

• Bachelor's degree in life sciences or Registered Nursing certification or equivalent
• Minimum 6 months of travel-based clinical monitoring experience
• Knowledge of ICH-GCP guidelines, applicable regulations, and standard operating procedures
• Valid driver's license; must live within 60 miles of major airport
• Legally authorized to work in United States without sponsorship
• Proven clinical monitoring skills and medical/therapeutic area knowledge
• Proficiency with Microsoft Office and ability to learn clinical trial software