Clinical Resarch AssocaiteIn-House Oncology or I&I

Role: Clinical Trials Manager supporting Phase I-III oncology or immunology trials, overseeing site monitoring, vendor management, study startup, and regulatory documentation. Responsibilities include 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, and supporting study initiation and close-out tasks. Collaboration involves working with Clinical Operations, Regulatory, Data Management, Biostatistics, Pharmacovigilance, and external vendors. Qualifications: 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. High-Value: Oncology (solid tumor, hematologic), Phase 1/2 trials, sponsor oversight, vendor management, GCP compliance, oncology endpoints. Work setup: Hybrid in Boston with 70% office presence, 30-40% travel for site visits, co-monitoring, investigator meetings, and international activities.