As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
At Fortrea, we're trailblazers in the biopharmaceutical industry with over 30 years of experience. Our mission is to revolutionize healthcare through cutting-edge research, innovation, and an unwavering commitment to excellence. Join our passionate team dedicated to transforming patient outcomes and make a real impact in the world of clinical research.
Why Fortrea?
Innovative Culture: Be part of a dynamic team that values creativity and fresh ideas.
Career Growth: Access continuous professional development opportunities to advance your career.
Work-Life Balance: Enjoy a flexible work schedule that lets you balance your professional and personal life.
Role Overview:
As a Clinical Research Associate II (CRA2) at Fortrea, you'll be at the forefront of global clinical trials, ensuring compliance and maintaining top-tier data integrity. This is your chance to work directly for a dedicated sponsor and be involved in cutting-edge trials that could significantly improve patient health outcomes.
Key Responsibilities:
1. Monitor Clinical Trials: Ensure studies adhere to protocols, amendments, and regulatory requirements.
2. Conduct Site Visits: Perform pre-study, initiation, routine monitoring, and close-out visits.
3. Manage Study Sites: Track regulatory submissions, recruitment, CRF completion, and data query resolution.
4. Effective Communication: Liaise with sponsors, investigators, and stakeholders for smooth trial execution.
5. Data Integrity: Ensure accurate data collection, documentation, and report submissions.
6. Documentation Preparation: Assist in creating and reviewing study protocols, CRFs, and informed consent forms.
7. Training and Support: Provide training to site staff for compliance with trial protocols and objectives.
8. Risk Management: Evaluate and manage risks to ensure trial integrity and participant safety.
Qualifications:
9. Educational Background: Bachelor’s degree in a scientific or health-related field (advanced degree preferred).
10. Experience: confident in clinical research site management and monitoring, ideally within a CRO or pharmaceutical setting.
11. Regulatory Knowledge: Strong understanding of ICH-GCP guidelines and clinical trial regulatory requirements.
12. Trial Monitoring: Proven success in monitoring Oncology phase I, II, or III global studies.
13. Skills: Excellent communication, organizational, and time management abilities.
14. Travel: Willingness to travel as needed for site monitoring.
Ready to make a difference? Join Fortrea and be part of a team that's shaping the future of healthcare. Apply today!
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.