We are seeking a detail-oriented and proactive Sr. Clinical Trial Associate (Sr. CTA) to support the successful execution of clinical studies within Clinical Operations. In this role, you will partner closely with study leads and cross-functional teams to manage key components of clinical trials, ensuring delivery against timelines, budgets, and quality standards.This is an excellent opportunity for a clinical operations professional who thrives in a fast-paced environment and is eager to contribute to high-impact clinical programs.Study Team & Meeting ManagementCoordinate cross-functional study team meetings, including agenda development and meeting minutesSupport clinical site start-up activities and ongoing site management effortsAssist in managing external vendors and ensure alignment with study expectationsParticipate in, and occasionally present at, Investigator MeetingsStudy Documentation, Tracking & ExecutionMaintain and track study documentation to ensure compliance with internal standards and regulatory requirementsSupport Trial Master File (TMF) management, including document filing and quality controlAssist with development, editing, and distribution of key study documents (e.g., informed consent forms, manuals)Maintain study trackers, tools, and systems to support study executionStudy Planning & Quality OversightAnalyze clinical systems and processes to identify risks to data quality and integrityProvide input into protocol feasibility and identify opportunities to optimize study deliveryDevelop and manage study timelines, proactively identifying risks and escalating issues as neededSupport clinical trial budgeting activities and cost trackingTrack regulatory documents (e.g., 1572s) and collaborate with Regulatory on submissions such as INDsSupport sample management and contribute to review of core study documents as applicable
