• Collaborate with team members in the evaluation and establishment of clinical study sites by performing site qualification visits to ensure applicability of sites for planned study. • Collaborate with Senior Clinical Research Associate to create source documentation/CRFs in alignment with protocol requirements. • Create consent and assent templates specific to the needs of the planned study. • Collaborate with sites and internal stakeholders to align and implement site specific language for each consent/assent. • Train site staff on protocol requirements, source documentation, and case report form completion. • Serve as the primary liaison with Institutional Review Board (IRB) in the preparation and submission of all study related documentation including but not limited to the study protocol, consent/assent, user guides, training presentations, Curriculum Vitaes (CVs), licenses, and study amendments. • Conduct regular monitoring visits to ensure study protocol compliance, primary data collection is recorded properly, and appropriate reporting is being conducted. • Coordinate project meetings. • Participate in the creation and review of clinical study reports for regulatory submission ensuring alignment of all the critical report elements such as adverse events, device deficiencies, etc. • Participates in team meetings and tracks action items. • Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines. • Performs other duties as required.