Sr. CRA 2, FSP – Invitro Diagnostics – Southeast
Company: Fortrea
Location: Remote – Southeast United States (NC, AL, SC, VA, GA, and others)
Job Type: Full-Time | Remote
Experience: Typically 4+ Years (Clinical Monitoring / CRA)
Qualification: University or College Degree, or relevant allied health certification (e.g., nursing licensure)
Salary Range: $125,000–$140,000
Job Overview
Fortrea is hiring a Senior CRA 2 (FSP) for in-vitro diagnostics studies in the Southeast U.S. The role involves leading and supporting clinical trial site monitoring, ensuring participant safety, maintaining data integrity, and coordinating local project activities. This position requires frequent overnight travel (50–60%) and the ability to adapt to fast-paced, technology-driven environments.
Key Responsibilities
Clinical Monitoring & Site Management
Responsible for all aspects of study site monitoring including routine visits, close-outs, and maintenance of study files.
Conduct pre-study and initiation visits and liaise with vendors as assigned.
Ensure study staff are properly trained and have necessary protocol materials.
Protect study participants by verifying informed consent procedures and protocol compliance.
Monitor Case Report Forms (CRFs) and other data collection tools for accuracy and completeness.
Manage registry activities and undertake feasibility work when requested.
Complete SAE reporting, narratives, and follow-up activities.
Data Review & Compliance
Independently perform CRF review, query generation, and resolution per established guidelines.
Ensure high-quality, accurate data collection and adherence to protocol standards.
Support training of new employees, including co-monitoring activities.
Project Coordination
Coordinate designated clinical projects as Local Project Coordinator with supervision as applicable.
Serve as a local client contact when assigned.
Perform other duties as directed by management.
Required Skills
Clinical & Technical Expertise
4+ years of clinical monitoring experience.
Knowledge of clinical trial protocols and regulatory requirements.
Ability to work in a fast-paced, technology-driven environment.
Communication & Teamwork
Strong interpersonal and team collaboration skills.
Ability to train and guide site staff and new employees.
Effective problem-solving and organizational skills.
Travel & Flexibility
Comfortable with frequent overnight domestic and occasional international travel.
Adaptable to changing priorities and rapid problem-solving on-site.
Basic Qualifications
University or college degree, or certification in a related allied health profession (e.g., nursing licensure).
Preferred Competencies
Experience with electronic data capture (EDC) systems.
Understanding of in-vitro diagnostics therapeutic area.
Ability to manage multiple study sites and projects simultaneously.
Key Competencies
Clinical trial site monitoring
Participant safety and informed consent verification
Data review and CRF validation
SAE reporting and follow-up
Project coordination and client liaison
Regulatory compliance and protocol adherence
Work Environment
Office and remote environment with exposure to electrical office equipment.
Frequent travel to client and study sites; occasional international travel.
Physical requirements include extended sitting, repetitive hand movements, bending, lifting (15–20 lbs), and use of computer software.
About the Company
Fortrea partners with leading pharmaceutical, biotechnology, and medical device companies to support clinical research and drug development, focusing on participant safety, data integrity, and operational excellence.
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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