• Conduct remote or on-site visits to assess protocol and regulatory compliance • Monitor investigator sites with a risk-based monitoring approach and ensure data accuracy • Document observations in reports and letters in a timely manner • Facilitate effective communication between investigative sites and the project team • Maintain and complete administrative tasks such as expense reports and timesheets

• Oversee and manage clinical trial sites, ensuring that studies are conducted in accordance with regulatory requirements, study protocols, and company standards. • Focus on coordinating clinical trial monitoring delivery, resolving issues, and developing team capability. • Lead site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines. • Serve as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance. • Ensure the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations. • Mentor and provide guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies. • Collaborate with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials.

• Oversight of monitoring effectiveness • Implements various types of oversight encounters and activities • Completes Sponsor Oversight Visit reports consistently • Utilizes a risk-based approach to review critical to quality items • Creates Study Specific Oversight Plans (SSOPs) for aligned trials • Troubleshoots and uses alternative and innovative approaches to solve problems • Builds relationships with investigators and site staff in region

• As a Senior CRA, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. • You will build and maintain relationships with clinical sites and investigators. • Your focus will be on subjects’ rights, safety and well-being and quality of data compliance. • Responsibilities will include conducting and reporting all types of onsite monitoring visits, driving the study startup phase, performing CRF reviews, source document verification and query resolution.