Senior Clinical Research Associate (Texas Region)

Role: Senior Clinical Research Associate (CRA) responsible for site management and monitoring activities within CNS clinical trials. Objectives include ensuring trial compliance with ICH/GCP, regulatory standards, and SOPs across assigned sites, primarily in Texas. Responsibilities encompass site evaluation, initiation, monitoring, and close-out visits; data review for accuracy; documentation; site training; and escalation of issues. The Senior CRA may lead in-house data reviews, mentor junior staff, oversee CRO/vendor performance, and support study planning and management. Qualifications: minimum 5 years of clinical trial experience, including 5+ years of on-site monitoring, with a background in pharmaceutical, biotech, CRO, or healthcare settings. A BA/BS in a scientific or healthcare field is preferred; strong knowledge of FDA regulations, ICH/GCP guidelines, and clinical operations is required. Experience in CNS trials and vendor interactions is advantageous. Skills include proficiency in Microsoft Office, CTMS, eTMF, and eCRF systems, with excellent communication, organizational, and problem-solving abilities. The role demands critical thinking, adaptability, and the ability to multi-task in a fast-paced environment. Travel up to 70% is expected. The position reports to the Clinical Trial Manager or Director, with potential leadership responsibilities such as mentoring and overseeing monitoring activities.