Responsibilities:Provide sponsor oversight of assigned investigative sites, serving as the primary operational and ensuring high – quality protocol execution, and compliance with GCP, and regulatory requirementsMonitor site performance through centralized and remote review of study data, key performance metrics, and monitoring outputs, including proactively identify and escalate issues with recommended mitigation strategiesSupport study start-up, conduct, and close-out activities, including site feasibility, activation, training, and close-out documentationEnsure timely collection, review, and maintenance of essential regulatory documents and maintain Trial Master File (TMF) completeness, quality and inspection readinessPartner with Clinical Trial Managers and CRO monitoring teams to provide sponsor oversight and ensure monitoring activities align with the study’s risk-based monitoring strategyTrack and analyze protocol deviations, safety events, data discrepancies, and site performance trends; collaborate with cross-functional teams to drive timely resolutionSupport regulatory and inspection readiness by overseeing IRB/EC submissions and approvals, maintaining accurate site documentation, and contributing to audit and inspection preparation, responses, and follow-up activitiesCollaborate cross-functionally with Clinical Operations, Data Management, Safety, Regulatory Affairs, and Biostatistics, and support sponsor oversight of CROs and otherParticipate in investigator meetings, study team meetings, and internal governance as requiredQualifications:Bachelor’s degree in relevant scientific discipline with 2-5 years of experience in clinical research, clinical operations or healthcare-related roles or equivalent combination of education and experiencePrior experience as a Clinical Trial Assistant (CTA), Study Coordinator, or similar clinical research role requiredWorking knowledge of ICH-GCP, FDA regulations, and global clinical trial requirementsExperience with sponsor systems EDC, eTMF, CTMS and centralized monitoring toolsStrong analytical skills with the ability to interpret study and site-level performance trendsExcellent written and verbal communication skills with high level of attention to detailDemonstrated sponsor mindset with a focus on quality, accountability, and complianceAbility to work independently while escalating issues appropriatelyStrong problem abilities and proactive risk identification skillsEffective collaboration and stakeholder management abilitiesThrives in a collaborative environment and enjoys working cross-functionally to solve operational challenges. Building on prior experience in a Clinical Trial Assistant (CTA) or similar role, the CRA II independently manages assigned sites and supports study oversight of clinical trial execution.