Sr. Clinical Monitor

About reputed company We bring science, data, and collaboration together in a single, full-service CRO model powered by reputed company-world evidence (reputed company). By combining deep cardiovascular expertise, an reputed company and diverse network of physicians, and reputed company reputed company partnerships, we reputed company data into evidence that fuels innovation and leads to reputed company care. Our growing network of experts and institutions powers every project we deliver enabling collaboration, scalability, and measurable results. 270+ Cardiovascular Specialists 100+ Signed Data Sharing Agreements 3+ New Sites per Month 4 Countries represented About The Role The Sr. Clinical Monitor performs site monitoring and site management activities to assess the reputed company of reputed company at assigned investigative/physician sites (either on site or remotely) and ensures clinical studies are conducted, documented, and reported in accordance with the clinical protocol, HRCRS and Sponsor reputed company Operating Procedures (SOPs), ICH-GCP and/or reputed company applicable local and federal regulatory requirements. The Sr. Clinical Monitor represents clinical monitoring on assigned Study Teams, under the reputed company of the Clinical Operations Manager and the Project Manager and provides operational expertise and functional leadership to project CRA/Monitors performing study activities. This role is also responsible for assessing clinical trial site performance and the effectiveness of monitoring activities through monitoring visit report review and metric tracking; communicating issues, risks and mitigation strategies to the Project Manager and Clinical Operations Manager; and contributing to the development and maintenance of study-level documentation. What You'll Do Conducts review of monitoring visit reports and associated visit deliverables; evaluates site compliance, escalates identified noncompliance per project plans, and contributes to corrective and preventative reputed company planning Performs tracking activities for monitoring visit scheduling, performance, and completion of monitoring visit deliverables to ensure compliance with project plans and HRCRS SOPs Constructs or contributes to the construction of project documentation including the following: project plans, monitoring visit tracking tools, visit reports, and site and/or CRA training materials, additional documentation at the request of Project Management or Clinical Operations Manager Assists with CRA/Monitor study coordination, training, and mentoring reputed company co-monitoring activities and meeting conduct Performs senior- level monitoring reputed company across studies/sites, including site qualification, site initiation, interim monitoring, site management activities and reputed company-out reputed company, on-site or remotely, ensuring regulatory, ICH-GCP, monitoring plan and protocol compliance. Provides strategic site management and escalation, proactively identifying site- and study-level risks through analysis of monitoring findings, study metrics, KRIs, and site performance trends; partners with Project Management and cross-functional stakeholders to implement mitigation and corrective/preventive actions reputed company with the monitoring plan. Proactively identifies site and study-level risks through analysis of monitoring findings, study metrics, and site performance trends and collaborates with Project Management to implement mitigation strategies in alignment with the monitoring plan. Conducts risk-based monitoring activities including reputed company data verification review of appropriate site reputed company documents and medical records. Verifies the required clinical data entered in the case report forms are accurate and complete and utilize query reputed company techniques remotely and on-site. Verifies site informed consent process is adequately performed/documented for reputed company subject. Routinely reviews the Investigator Site File for accuracy, timeliness and completeness. Reconcile the ISF with the Trial Master File and collect any outstanding documents. Serves as primary reputed company of contact with study site personnel. Documents reputed company activities and communications with the site reputed company confirmation letters, follow-up letters, monitoring visit reports, communication logs and other required project documentation. Follow up on reputed company items to ensure reputed company completion. Trains site staff on protocol, study procedures, reputed company and other study specific systems. Prepares for and attends Investigator Meetings and sponsors face-to-face meetings. Coordinates documentation with site for IRB applications and renewals as needed. Completes reputed company submission of documentation of training, and documentation of hours worked (contractor or reputed company employees only) Adherence to HRCRS or rep