Specialist, Clinical Trials

Role: Clinical Operations Coordinator supporting planning, initiation, conduct, and closeout of domestic and global clinical trials at Neurocrine Biosciences. Responsibilities: assist in trial document management, IRB/IEC submissions, site coordination, and monitoring activities; ensure compliance with GCP, FDA, EU regulations; support study start-up, vendor management, and eTMF oversight. Requirements: BS/BA in Science or related field; 2+ years in clinical trials or operations, with CRO/vendor management exposure preferred; working knowledge of clinical drug development, GCP, FDA, and EU guidelines; strong organizational, communication, and analytical skills; proficient in project management tools. Preferred: Master’s degree, experience with monitoring or trial management, familiarity with clinical industry standards. High-Value: early to late-phase trials, international sites, document management, IRB/IEC coordination, GCP compliance, cross-functional collaboration. WorkSetup: not specified, but likely hybrid or on-site based on trial activities.