Senior Clinical Research Associate
Core
Senior Clinical Research Associate providing operational management and daily oversight of study timelines, deliverables, and CRO/vendor performance for solid tumor and cell therapy clinical trials.
Role type
Senior Clinical Research Associate (Sponsor/CRO)
Builds
Clinical trial operations for tumor infiltrating lymphocyte (TIL) cell therapies and immuno-oncology programs
Domain
Biotechnology / Cell Therapy / Oncology
Required skills
Clinical trial management, Vendor oversight, GCP/ICH guidelines knowledge, Protocol development, Regulatory documentation management, Data review, Site activation tracking, Risk management, Budget reconciliation, TMF maintenance
Preferred skills
Prior on-site monitoring (CRA) experience, eTMF/CTMS systems proficiency, CRO/vendor budget tracking
Technologies
eTMF, CTMS, MS Office Suite
Responsibilities
Manage study start-up activities, Review CRO monitoring reports and action items, Lead vendor management activities, Perform routine data listings review, Collect regulatory documentation, Mentor junior staff, Assist in protocol and document development, Maintain Trial Master File (TMF), Prepare study status updates
Seniority
Senior, hands-on IC
