• Primarily a training and development role, this position will support and observe clinical site monitoring services both inhouse and in the field whilst developing CRA skills and knowledge. • This role will have exposure and training in all aspects of the clinical site monitoring services whilst providing monitoring and site management activities for full-service studies assessing for protocol, SOP, and regulatory compliance. • Responsibilities include site management activities to help drive investigative site and patient recruitment, compliance, and oversight. • Conduct remote data review, support data query and closure activities, support Risk Based Monitoring (RBM) activities, assess data collection and (regulatory) document collection, perform remote and onsite activities for investigational sites including site contacts, qualification, initiation, monitoring and close out visits under supervision and/or independently and in accordance with corporate, sponsor and regulatory (ICH GCP and other) standards and guidelines. • Represents the corporation by maintaining collaborative relationships with stakeholders.

• Perform all site monitoring visit activities • Participate in the site selection process • Provide feedback to assist sites with resolution of detected deficiencies • Contribute to the development and review of protocols, study tools, and materials • Provide mentoring, training, and co-monitoring of junior clinical team members • Develop and maintain effective working relationships with clinical sites • Attend and present at meetings and conferences • Participate in the RFP process, including business development meetings • Participate in internal initiatives and standard operating procedures • Perform both onsite & remote monitoring and study closure activities

• Perform all site monitoring visit activities, inclusive of all study visit types (PSV, SIV, IMV and COV) • Participate in the site selection process with oversight from the Clinical Team Lead role • Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed, follow-up with sites until deficiencies are resolved • Contribute to the development and review of protocols, study tools, and materials as well as documentation for clinical trials • Provide mentoring, training, and co-monitoring of junior clinical team members • Develop and maintain effective working relationships with clinical sites and within Rho as well as ensure communication of project goals and critical requirements • Attend and present at meetings and conferences, including Investigator Meetings • Participate in the RFP process, including business development meetings • Participate in the Clinical Operations community at Rho by contributing to internal initiatives and standard operating procedures for the administration and monitoring of clinical trials • Perform both onsite & remote monitoring and study closure activities across multiple protocols

• Senior CRA will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. • Monitoring will be conducted in line with the Study Monitoring Plan (SMP) and will be performed virtually for the majority of activities to supplement on site visit requirements. • Collaborate with the Site Manager to assure that the site complies with the protocol and is inspection ready and will coordinate with institutions and investigators at the local level. • Conduct monitoring activities using different methods, (e.g., both on site and remote). • Conduct source document review and verification of appropriate site source documents and medical records. • Manage reporting of protocol deviations and appropriate follow up. • Drive query resolution to closure within agreed timelines. • Document activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP. • Reviews data entry timeliness in line with outlined requirements, missing pages, outstanding data queries, timelines for database locks. • Checks site specific logs are complete and up to date.