Clinical Research Associate Role at Thermo Fisher Scientific USA
Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) in FSP Oncology for Georgia and Florida. This fully remote clinical research job offers an exciting opportunity to contribute to life-changing therapies, ensuring data accuracy, regulatory compliance, and effective site monitoring while advancing your career in clinical research.
Job Details:
- Job Type: Full-time
- Category: Clinical Research
- Location: Georgia / Florida (Fully Remote)
- Work Schedule: Standard Mon-Fri
- Environmental Conditions: Office
About Thermo Fisher Scientific:
Thermo Fisher Scientific empowers scientists and healthcare professionals worldwide to make the world healthier, cleaner, and safer. As a leading global contract research organization (CRO), the company supports clinical trials in 100+ countries, offering innovative solutions and research services to develop life-changing therapies. Joining Thermo Fisher Scientific careers means contributing to meaningful global impact in clinical research. Apply for more jobs in the US.
Educational Requirements Clinical Research Associate role:
- Bachelor’s degree in a life sciences field or Registered Nursing certification.
- Relevant combination of education, training, and/or experience may be considered equivalent.
Key Responsibilities:
- Monitor investigator sites using risk-based approaches and implement corrective actions.
- Ensure data integrity through SDR, SDV, and CRF review via on-site and remote monitoring.
- Conduct investigational product inventory and records review.
- Document observations and escalate issues promptly to clinical management.
- Maintain communication with sites between visits to ensure protocol adherence.
- Participate in investigator meetings, site initiation, and trial close-out activities.
- Ensure essential documents comply with ICH-GCP and regulatory standards.
- Provide trial status tracking and progress updates to the Clinical Team Manager.
- Facilitate communication between investigative sites, clients, and project teams.
- Respond to audits, inspections, and company regulatory requirements.
- Complete administrative tasks including timesheets and expense reports.
- Support project publications, tools, and process improvement initiatives.
Skills Required for Clinical Research Associate role:
- Proven clinical monitoring skills and therapeutic knowledge.
- Strong understanding of ICH GCPs, regulations, and procedural documents.
- Critical thinking, problem-solving, and risk-based monitoring capabilities.
- Effective oral and written communication skills.
- Strong organization, time management, and attention to detail.
- Ability to work independently or in a team environment.
- Proficiency in Microsoft Office and other relevant software.
- Flexibility and adaptability in various scenarios.
- Professional presentation and interpersonal skills.
Benefits of the Role:
- Fully remote work flexibility.
- Opportunity to contribute to life-changing therapies.
- Career growth within a leading global CRO.
- Exposure to innovative clinical research frameworks.
- Part of Thermo Fisher Scientific careers offering meaningful global impact.
