• Plans and leads execution of the day to day activities for the monitoring of a clinical study andcommunicates consistently with the clinical team providing project objectives, expectations andstatus updates.• Ensures the successful activation of trial sites according to time, quality/scope and budgetparameters.• Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up and resolution of site issues.• Forecasts as per the contractually agreed FTE, tailoring forecasts to peaks and flows of activitiesthroughout the project duration.• Liaises with Clinical Operations Managers to resolve clinical resource and performance issues.• Creates and maintains project specific plans, documents and tools for the clinical team.• Plans, oversees and conducts initial and ongoing training for the relevant study staff on clinicalproject specifics.• Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies.• Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution.• Collaborates with Quality Assurance to identify sites needing corrective and preventativeaction plans; assists with audit responses.• Forecasts units and hours and generic resources for the start-up and monitoring activities,determines worked units and hours, analyzing forecasted and worked activities to ensure adherence to contract and budget.• Ensures no out-scope tasks be conducted without the required evidence of agreement from the client or approval by the relevant PRA staff.• Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved.• Participates in client meetings, assisting with presentations as required.

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites • Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely • Provides regular site status information to team members, trial management, and updates trial management tools • Completes monitoring activity documents as required by PRA SOPs or other contractual obligations • Performs essential document site file reconciliation • Performs source document verification and query resolution • Assesses IP accountability, dispensation, and compliance at the investigative sites • Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines • Mentors junior level CRAs and serves as a resource for new employees • Serves as observation and performance visit leader • Schedules and reviews trial tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with PRA’s policies, procedures, and SOPs, and ensures HR processes are properly implemented • Serves as a Preceptor for new CRAs participating in the CRA Bridge Program • Serves as subject matter expert for Clinical Trial Managers (CTMs) on monitoring related activities Visit Leader• Performs risk based monitoring visits when needed• Performs Quality Assessment visits for other CRAs• Available for complex visits when specialized CRAs are needed

• Site monitoring visits, including site activation, interim study monitoring and closeout visits. • Site visit preparation, including initiation activities, tracks submission of essential regulatory documents, helps determine when a site is ready for initiation, schedules and leads site initiation visit, etc.• Coordinates and schedules monitoring visits, (e.g., interim monitoring visits)• Writes and distributes site visit reports within established timelines, and tracks resolution of outstanding issues.• Meets monthly with NIAID project officer to review status of protocols and projects.• Main contact for NIAID project officer for multiple protocols.• Prepares and reviews draft protocols and amendments, as well as corresponding informed consent documents.• Reviews, contributes to, and processes project documents and required reports; such as annual reviews, severe adverse events, protocol deviation, and participant accrual.• Collects, reviews, and maintains regulatory documents. • Prepares and reviews study and project materials, (e.g., Manual of Operating Procedures (MOPs), User’s Guides, Data Management Handbooks, and SOPs).• Reviews, implements, and evaluates validation processes. Generates queries and distributes anomaly reports to help resolve data discrepancies.• Coordinates with project statistician to develop and produce project-specific reports.• Conducts training sessions for site personnel on GCP, study protocol requirements, EMMES data systems and data management practices.• Participates in internal audits and other project and corporate quality assurance activities, • Teaches introductory protocol monitor course internally, through EMMES.• Develop case report forms (CRFs) based on protocol and data collection requirements. • Leads conference calls with coordinators, sites, and PIs; prepares agenda and summaries.• Reviews project budget monthly to keep within contract.

• Travel to CHOP, Vanderbilt, and the University of San Francisco to coordinate the follow-up for the Management of Myelomeningocele study (MOMS)Elizabeth FricksPage 3• Schedule visits for patients, and their families, with the physicians and examiners.• Assist with the completion of follow-up forms to ensure accuracy.• Review MOMS follow-up forms after follow-up visits with patients.• Work with the Principle Investigator for the biostatistics coordinating center (BCC) to schedule and coordinate meetings with the National Institute of Child Health and Development (NICHD), the BCC, and the hospitals within the Maternal Fetal Medicine network (MFMU).• Manage prediction of MFMU and MOMS budgets.• Review invoices from subcontractors and laboratories.• Help write budget renewals for MFMU.Clinical Research Assistant • Study coordination and monitor the collection of data for the Maternal Fetal Medicine Units Network.• Update the collection of data and review data quality using SAS programs.• Assist with the generation of SAS programs for the purpose of creating data checks.• Assure the laboratory has processed and assayed biological samples per protocol guidelines. • Manage active/placebo dose adjustments for clinical trial participants.• Assist the pharmaceutical company with assuring medication is distributed to centers efficiently.• Maintain records of protocols, amendments, and any changes to the study.• Certify clinical centers and nurses for participation in the clinical trial.• Generate, update, and maintain study documentation.• Act as liaison between nurse coordinators at the clinical centers and the Biostatistics Center.