• Coordinates and conducts GCP and study protocol training at study sites and assures training is documented • Builds rapport with study site staff to assure compliance with the protocol, applicable regulatory and guidance documents, SOPs, and all study activities • Assists in reviewing the study records and all study notebooks to ensure contents are current and complete • Assists in providing tracking and Quality Control (QC) of data as required and assists with responses to QA audits • Evaluates Investigators and assists with selection of appropriate sites to conduct clinical studies • Collaborates with the study Project Manager to assure study sites selected meet the needs of the study protocol • Monitors assigned study sites through review of electronic data capture (EDC) systems, faxed, emailed, and paper documentation • Serves as the liaison between Argenta US Clinical and study site personnel • Facilitates clarifications, corrections, and data query resolution with study sites or data management personnel • Tracks adverse events (AE’s) encountered in clinical studies and ensures all serious AEs and non-serious AEs are documented and communicated appropriately to the Project Manager and Sponsor • Learns to assist with facilitates clarifications, corrections, and data query resolution with study sites or data management personnel • Builds relationships with key individuals and contributors in the organization and beyond

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study • Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements • Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies • Create annotated visit report templates and other documents and strategies related to site management and monitoring • Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented • Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements • Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control • Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team • Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed

• Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits • Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion • Manage and track the preparation and return of investigational supplies at individual sites • Monitor and document investigational product dispensing, inventory, and reconciliation • Monitor and document laboratory sample storage and shipment • Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities • Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues • Review data queries and listings, and work with study centers to resolve data discrepancies • Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues • Maintain complete and accurate study files and review files to ensure all appropriate documentation is present • Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials • Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues

• Monitor clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit including qualification, initiation, interim, and close out site visits • Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion • Manage, prepare, send, track, and return investigational supplies at individual sites • Monitor and document investigational product dispensing, inventory, and reconciliation • Monitor and document laboratory sample storage and shipment • Monitor trial by reviewing and reporting on site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities • Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues • Review data queries and listings, and work with the study centers to resolve data discrepancies • Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues • Maintain complete and accurate study files and review files to ensure all appropriate documentation is present • Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials • Follow Good Documentation Practices, complete Visit Reports and site correspondence in accordance with SOPs