• Join us in redefining what it means to work for a CRO. • Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges. • You will play an integral to driving project success. • You’ll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and Rho Standard Operating Procedures. • You’ll need proven monitoring skills in order to conduct site visits to assess site adherence to protocol and regulatory requirements as well as manage required documentation. • You will also be responsible for ensuring the data remains audit ready and able to pass an audit by Rho, the Sponsor, or a regulatory agency. • This position is a remote role to be located within a 1-hour commute of a US metropolitan airport with the commitment to conduct 8-10 site visits days per month (up to 80% travel).

• 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