• Acting as a Project Lead under the supervision of the Project Manager on Phase I-III Oncology clinical trials and collaborating with the study team on study related activities, including study initiation activities (i.e., site feasibility, contract/budget negotiations, vendor selection, collecting essential documents, preparing and distributing of Clinical Trial Supplies), study maintenance activities and study completion.• Participating in the preparation and/or review of draft study documents (i.e., protocol, ICFs, eCRF guidelines, monitoring plan, and other study manuals).• Preparing and conducting training sessions for site personnel/site monitors or facilitating other study team meetings, related to any of the following topics: study protocol, ICH-GCP, electronic data capture/data management, vendors, cohort management meetings, safety updates, issue management/resolution and/or discussing relevant study updates. • Supporting the Site Monitors in the collection, review and maintenance of both paper and electronic Trial Master Files to ensure completeness and accuracy with all applicable regulatory requirements and internal practices.• Reviewing data reports/listings for inconsistencies, trends, missing data and/or incomplete data, as well as, reviewing SAE reports, protocol deviations, vendor queries (i.e., missing lab samples) and other study status reports to confirm completeness and compliance with the study protocol and applicable regulatory agencies. • Contributing in internal audits and other project or corporate quality assurance activities and/or assisting with the implementation of a Corrective Action Plan.

• Performing site selection, initiation, interim monitoring and close-out visits in accordance with contracted scope of work, monitoring plan and good clinical practice.• Administering protocol and related study training to assigned sites and establishing regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluating the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalating quality issues and/or assisting with the implementation of a corrective action plan.• Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Creating and maintaining appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.• Acting as a mentor to less experienced CRAs, performing Accompanied Site Visits, reviewing their performance and providing feedback to their line managers.• Participating in a committee dedicated to improving different work processes within the company, as well as, a mobile Site Visit Report (mSVR) pilot program for iPad/PC, and a pilot program for Microsoft OneNote.

• Performed co-monitoring visits, where responsibilities include: traveling to the site, reviewing the Investigator Site Files (ISFs) for completeness and accuracy, conducted safety letter reconciliation, and performed drug accountability.• Assisted study team members with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.• Collaborated with Clinical Project Manager (CPM) and other study team members on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.• Handled periodic reviews of both paper and electronic study files to ensure accuracy and completeness. • Collaborated with the study team on the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Coordinated the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Acting as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• Entered patient visits into the company’s clinical systems and initiated payment to the investigator.• Electronic Trial Master File (eTMF) Champion, where duties included: assisting IQVIA employees with all eTMF inquiries, researching resolutions, attending bi-weekly teleconferences, assisting with enhancements to the system, as well as presenting system updates and any recent lessons learned at our periodic departmental eTMF forums.• Member of the Quintiles CTA Social Committee, where tasks included: planning social events in our local office as well as helping to coordinate regional CTA events in order to help deliver communication and training modules to all CTAs regionally.• Performing assigned administrative tasks to support team members with clinical trial execution.

• Supported Phase II-III investigational studies from study initiation to study completion.• Assisted the study team with site feasibility documents, start-up documents, correspondence, clinical trial documentation and supported study close-out activities.• Prepared investigator site start-up binders/bins and ensured completeness and accuracy of study documents.• Maintained study documents submitted by the site or other study personnel through a clinical operations mailbox.• Collected pertinent regulatory documents at study start-up, performed a quality check of these documents and other study related materials and reported discrepancies to the responsible CRA. • Initiated and maintained TMFs according to internal SOPs, ICH guidelines and federal regulations.• Reviewed study files to ensure inspection readiness and regulatory compliance for FDA and QA audits.• Created and updated a TMF filing checklist and other trial spreadsheets according to internal procedures.• Processed study related data in the IMPACT database and generated monthly reports.• Generated and tracked CDAs for the duration of the study.• Scheduled and assisted with the coordination of study team meetings, prepared and organized meeting materials and handled meeting minutes.

• Supported several Clinical Trial Managers (CTMs) and the Clinical Operations Director on Phase I-II investigational studies in all areas of study implementation (CRO selection, Site Feasibility, Recruitment, Start-Up, Study Conduct, Close-Out, Reconciliation and QA Review).• Initiated and maintained paper TMFs according to internal SOPs, ICH guidelines and federal regulations.• Performed a pre-audit of paper TMFs to ensure inspection readiness and regulatory compliance for FDA and QA audits.• Reviewed study related materials (i.e., draft protocols, monitoring plans, etc.)• Maintained contact with sites, investigators, CRAs and CRO personnel.• Coordinated and tracked CTAs, CDAs and MSAs.• Handled meeting arrangements for internal and off-site meetings (i.e., Investigator Meetings).• Attended department planning meetings and involved in SOP development.• Participated in kick-off meetings, site initiation visits, conference calls and other study team meetings.• Ensured safety data and AEs are reported in a timely manner prior to dosing and distributed safety data and AE listings to team members when received from the site(s).• Booked travel arrangements, conducted literature searches, initiated contact phone calls with vendors, scheduled teleconferences and/or webinars and processed expense reports.