Clinical Resarch AssocaiteIn- Oncology or I&I

Clinical Trials Manager supporting Phase I-III oncology or immunology trials, overseeing site monitoring, vendor management, study startup, and regulatory documentation.

• supervising CRO/vendor performance
• ensuring compliance with GCP and FDA regulations
• conducting site visits and monitoring activities
• reviewing data and documentation
• managing site issues and deviations
• supporting study initiation and close-out tasks

Collaboration involves working with Clinical Operations, Regulatory, Data Management, Biostatistics, Pharmacovigilance, and external vendors.

• Bachelor's in life sciences, nursing, pharmacy, or related field
• 4+ years of clinical monitoring experience, including at least 1 year on-site CRA work
• strong knowledge of ICH GCP, FDA regulations, and sponsor oversight
• proficient with EDC, CTMS, and eTMF systems, preferably Medidata Rave
• Experience in oncology, particularly solid tumor or hematologic malignancies, Phase 1/2, RECIST 1.1, and risk-based monitoring is required
• Certifications like SoCRA/CCRA or ACRP preferred

• Oncology (solid tumor, hematologic)
• Phase 1/2 trials
• sponsor oversight
• vendor management
• GCP compliance
• oncology endpoints

Hybrid in Boston with 70% office presence, 30-40% travel for site visits, co-monitoring, investigator meetings, and international activities.