Fortrea is a leading global Contract Research Organization (CRO) specializing in clinical development and patient access solutions. With a commitment to scientific excellence, Fortrea supports biopharma and medical device companies in accelerating drug development while ensuring regulatory compliance and patient safety.
Job Description: Clinical Research Associate II (Oncology)
Key Responsibilities:
✔ Site Monitoring & Compliance:
- Conduct pre-study, initiation, routine, and close-out visits per ICH-GCP, Fortrea SOPs, and sponsor requirements.
- Verify informed consent, protocol adherence, and regulatory document completeness in the eTMF.
- Ensure data integrity via source document verification (SDV), query resolution, and EDC review.
✔ Clinical Trial Management:
- Track investigational product (IP) accountability and study supplies.
- Assist in SAE reporting and follow-ups.
- Update eClinical systems (CTMS, EDC, eTMF).
✔ Stakeholder Collaboration:
- Train site staff on protocols and GCP.
- Attend investigator meetings and project teleconferences.
- Support new CRA training (co-monitoring).
✔ Travel Requirement: 60% (domestic/international) to study sites.
Eligibility & Qualifications
Minimum Requirements:
- Education: Bachelor’s degree in Life Sciences/Nursing/Pharmacy or related field.
- Experience: 3+ years as a CRA with Oncology trial experience.
- Skills:
- Strong ICH-GCP knowledge.
- Proficiency in eClinical tools (EDC, CTMS, eTMF).
- Fluency in English (written & verbal).
Preferred Qualifications:
- Phase I monitoring experience.
- Medical device/CRO background.
- Certification in clinical research (CCRA, ACRP).
Benefits at Fortrea
✅ Competitive salary & performance bonuses
✅ Health insurance & wellness programs
✅ Flexible work options (remote/hybrid)
✅ Career growth in global clinical research
✅ Travel allowances & expense reimbursement
How to Apply
📅 Last Date: July 31, 2025
