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In-House CRA II

Meet Life Sciences · United States

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Job SummaryThe In-House Clinical Research Associate (CRA) II supports clinical trial execution through remote monitoring, site support, safety reporting, and cross-functional collaboration. This role helps ensure trial compliance, data quality, and inspection readiness while supporting CRAs and clinical research sites throughout the study lifecycle.ResponsibilitiesConduct remote monitoring of clinical trials and support CRAs as a secondary point of contact for study sites.Ensure serious adverse events (SAEs) and other reportable events are identified, documented, and reported according to study protocols and regulatory requirements.Identify, document, communicate, and escalate compliance issues through monitoring activities, study metrics, and data reviews.Support study start-up, monitoring visits, data listing reviews, issue resolution, and audit/inspection readiness.Collaborate with cross-functional teams and study sites throughout all phases of clinical trials.Participate in study meetings, teleconferences, and training as needed.Maintain accurate trial documentation and support Trial Master File (TMF) activities.QualificationsBachelor's degree in a clinical, biological, scientific, or health-related field, or equivalent education, training, and experience.3–5 years of practical clinical trial experience, including experience performing core in-house CRA functions.Experience with remote monitoring, TMF documentation, and clinical trial compliance.Neurology or psychiatry clinical trial experience highly preferred.Experience working with Schedule I controlled substances strongly preferred.Study start-up experience is a plus.Preferred location: East Coast or Central U.S.