• Independently coordinate assigned study activities in compliance with protocols, SOPs, GCP, and regulatory requirements. • Screen and evaluate potential research participants for eligibility, documenting inclusion/exclusion criteria and escalating complex questions as needed. • Manage scheduling and execution of virtual and home-based study visits, assessments, and follow-up activities. • Collect, review, and enter study data accurately and in a timely manner using EDC systems and study tools. • Maintain complete, accurate, and audit-ready study documentation, including regulatory binders, participant records, and tracking logs. • Conduct or support informed consent discussions, ensuring proper documentation, version control, and regulatory compliance. • Serve as a primary point of contact for research participants and caregivers, addressing routine questions and coordinating logistics. • Prepare for and support sponsor, IRB, and regulatory monitoring visits, including responding to document requests and resolving findings. • Track and report study metrics such as enrollment, retention, deviations, and visit completion. • Identify operational risks or inefficiencies and proactively communicate improvement opportunities to research leadership. • Collaborate closely with investigators, care coordinators, and cross-functional teams to ensure a high-quality research experience. • Support onboarding and informal mentoring of junior research staff, as appropriate.