Nicole Cornett Email and Phone Number

• Assist manager in leading and mentoring the team of Protocol Interpreters to ensure productivity, quality and timeline metrics are met• Serve as scientific and clinical expert in the interpretation of clinical trial protocols (Oncology, Cardio, Neuro, Ortho, Vaccines, Women & Children)• Convert protocol details (schedule of events, lab/biomarker assessments, etc.) into visits and procedures while using a sponsor budget and adhering to Medicare Coverage Analysis (MCA)• Review protocol builds for accuracy, thoroughness, compliance, and sufficiency• Review all proposed amendments to understand the impact to the clinical trial. Adjust theschedule of events to capture any adjustments specified by trial amendments• Update Clinical Trial Management System (CTMS) with the updated schedule of events to ensure timely notification to impacted parties

• Serves as scientific and clinical expert in the interpretation of clinical trial protocols• Work directly with Scientific Director and/or Physicians and/or Program Managers to validate proper interpretation of the protocol• Prep for the Sarah Cannon Clinical Operations Protocol Review Committee by evaluating and assessing presenting protocols in advance to determine complexity, identify risks associated with a trial and operational and implementation challenges• Create and update the protocol specific Clinical Operation worksheet with pertinent study information to use as a study lead tool for Sarah Cannon Clinical Operations and applicable sites • Attend the Sarah Cannon Clinical Operations Protocol Review Committee to capture any details presented by the clinical and budget teams • Convert the protocol into a schedule of events which should be completed with each patient visit during the life of the study. • Review all proposed amendments to understand the impact to the clinical trial. Adjust the schedule of events to capture any adjustments specified by trial amendments. • Update the Clinical Trial Management System with the original or updated schedule of events to ensure timely notification to impacted parties • Provide initial clinical interpretation for each protocol and guide the Clinical Educators to insure consistent interpretation across the organization• Escalate all appropriate information to budgets, finance, or Clinical Operations management as deemed necessary• Report necessary metrics on appropriate timeframes

• Communicate effectively with the Invoicing Team, conveying goals and expectations while providing leadership and training to invoicing staff• Ensure that assigned tasks are completed within established deadlines• Perform original work on more complex issues and transactions• Direct invoicing processes to ensure timely and accurate invoicing• Assist in the development, documentation and implementation of departmental invoicing standards• Analyze and reconcile invoices as necessary• Work closely with Collections and Finance to quickly and effectively resolve outstanding issues• Prepare monthly reports for key indicators and statistics using QuickBooks and Excel. • Process/create other special reports as necessary• Maintenance of sponsor required software which used for invoice submission• Ensure that all processing and reporting deadlines are consistently achieved

•Create back-up and invoice for monthly and quarterly patient earnings revenue.•Review and process invoices for patient related hotel/travel and study related conference calls as per sponsor contract•Current invoicing of study invoiceable items/procedures•Establish, develop and maintain good working relationships with sites and vendors in order to resolve issues efficiently and in a timely manner•Generate all monthly invoices for multiple revenue types including general project management, patient enrollment milestones, data management fees, monitor visits and travel, site communications, pass-throughs and various other items as required per contract.•Generate other invoices as required for NRSU fees, Consulting, Scientific Meeting, PI and CTM/CTS travel, etc. •Process billing adjustments and corrections•Assist Finance and Collections departments as needed with requests and questions•Create QuickBook credits as requested after a thorough investigation•Update and maintain various logs used for monitoring invoice requests•Ensure that all processing and reporting deadlines are consistently achieved •Established the first training manual for the billing/invoicing team•Attend process improvement meetings to improve current manual processes

•Lead the execution of trials for the research team•Collect, complete and enter data into study-specific case report forms or electronic data capture systems within 10 days of patient visits•Confirm patient eligibility and discuss discrepancies with nursing staff and physicians•Verify screening procedures are performed within the protocol specified window•Enroll patients weekly•Monitor patient toxicities on trial according to Common Toxicity Criteria, including adding data to logs from source, confirming grades assigned by nursing staff, and ensuring consistency of data across the medical record•Plan and track all assigned clinical activity in the lifecycle phases of the start up, interim and close out•Educate Research Nurses and clinic staff on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments•Create study specific tools for source documentation including eligibility worksheets, screening checklists and site visit orders (SVO)•Ensure pharmacist has clinical and drug supplies•Track and report adverse events, serious adverse events, protocol waivers, deviations and violations•Participate in monitor visits monthly for each trial assigned•Review source documentation and queries for missing documentation•Maintain case report forms (CRFs)•Review trial data for clinical relevance and answers appropriate queries•Attend weekly teleconferences for each trial assigned to provide sponsor updates

•Support CTS to meet industry trial data deadlines•Obtain source documentation for patients enrolled into clinical trial•Assist CTS with case report form completion•Assist CTS with query resolution•Assist in SAE reporting and tracking•Create and maintain patient visit tracking spreadsheets for CTS•Maintain and archive study administrative file•Attend meetings as assigned and reports on actions.•Participate in educational activities and programs.•Work closely and effectively with all other department personnel.•Train new incoming Data Coordinators

•Respond to guest requests for special arrangements or services (e.g., transportation, reservations, dry cleaning) by making arrangements or identifying appropriate providers•Respond to special requests from guests with unique needs and follow up to ensure satisfaction •Gather, summarize, and provide information to guests about the property and the surrounding area amenities, including special events and activities•Answer, record, and process all guest calls, messages, requests, questions, or concerns•Contact appropriate individual or department (e.g., Bellperson, Housekeeping) as necessary to resolve guest call, request, or problem