• Management of a Phase II protocol • Assist with targeted responsibilities related to study start-up and feasibility• Manage clinical operational and quality aspects of allocated studies in compliance with ICH GCP• Ownership for achieving final clinical deliverables within the contractual time period• Review and/or management of timelines, study metrics, performance objectives, dashboards, financial over-burns and underspends, variance reporting, etc• Manage the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a trial• Manage clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum resources are allocated to maintain forward movement of clinical deliverables• Manage clinical budget• Manage contingency planning for data cleaning; clinical data listings review; coordinate process for reviewing data listings by a clinical team; escalate quality issues recognized; and provide CRA retraining for quality data as needed• Participate in site recruitment and budget negotiations• Provide leadership, coordination, and management of the PPD-customer joint project team through start-up, conduct, tracking, quality, and regulatory compliance management and close-out activities• Present at Investigator Meetings• Meet with CTMs/CRAs regularly to drive the completion of clinical deliverables and promote consistency and efficiency across projects• Work with CTMs/CRAs on organization, planning, strategy and process development • Prepare and present various CRA training modules and guidance in the management, training and development of CRAs• Serve as a hiring manager for CTMs and CRAs; responsible for assessing interview candidates for hire• Interact with assigned contact in QA to ensure project compliance with ICH GCPs, FDA CFRs, and local regulations• Manage vendors

• Demonstrated ability to appropriately review clinical data and proficient knowledge of medical terminology.• Understanding of FDA and ICH/GCP guidelines; working knowledge of PPD and/or Sponsor SOPs (when utilized) as appropriate.• Ability to utilize problem-solving techniques applicable to changing environment.• Identified issues and escalated to management as appropriate; present solutions and feedback.• Mentored and trained other monitors effectively and appropriately in the conduction, preparation and reporting of monitoring functions; provide feedback.• Ability to deal with difficult sites/study personnel and work with them effectively and without negativity.• Ability to work and plan independently in a detailed/organized fashion and/or work within a team.• Maintenance and/or development of various study-related tools.• Local and national ACRP member; committee member responsible for maintenance of local website.• Actively sought further development to improve performance and knowledge by way of continuing education, college, etc. Shares knowledge with peers and provides training/instruction as needed.

• Demonstrated ability to appropriately review clinical data and proficient knowledge of medical terminology.• Understanding of FDA and ICH/GCP guidelines; working knowledge of PPD and/or Sponsor SOPs (when utilized) as appropriate.• Ability to utilize problem-solving techniques applicable to changing environment.• Identified issues and escalated to management as appropriate; present solutions and feedback.• Mentored and trained other monitors effectively and appropriately in the conduction, preparation and reporting of monitoring functions; provide feedback.• Ability to deal with difficult sites/study personnel and work with them effectively and without negativity.• Ability to work and plan independently in a detailed/organized fashion and/or work within a team.• Maintenance and/or development of various study-related tools.• Local and national ACRP member; committee member responsible for maintenance of local website.• Actively sought further development to improve performance and knowledge by way of continuing education, college, etc. Shares knowledge with peers and provides training/instruction as needed.

• Performed Pre-Study, Initiation, Interim, and Close-Out Monitoring visits according to applicable Standard Operating Procedures (SOPs) and FDA guidelines.• Assisted CTM with trip report review• Developed collaborative relationships with investigative sites and client company personnel.• Primary contact for 1-11 assigned clinical sites. Responsible for the monitoring and management of the investigative site (monitoring activities, liaised with study coordinator, primary investigator, and SMO contact).• Created various study-related spreadsheets, documents, graphs, checklists, presentations, and reports used by the study managers or the study team during monitoring activities and/or training. • Provided training to the CRA team on study-related tools to ensure appropriate use, documentation, etc.• Trained newly assigned CRA team members.• Maintained local ACRP chapter website for posting on the national ACRP site• Reviewed informed consent templates for submission to central and local IRBs; suggested and tracked changes noted for project team. ICF Checklist utilized for all site and master templates.• Data management line listings.• Performed Accompanied Field Visits (AFVs) as requested for study team.

• Facilitated rapid study start-up and communication among different functional groups to ensure applicable timelines and metrics were met, 85 US Sites and 6 Mexico Sites• Performed non-clinical administrative tasks regarding all regulatory, legal and financial aspects of this study in accordance with FDA GCPs, ICH Guidelines and Global SOPs to include the preparation, sending, receipt, tracking, verification and transmission of all: • Regulatory Documents • IRB Submissions (Initial, Central Site, ICF Changes, etc.) • Clinical Trial Agreements and Indemnification Letters • Site Budgets and Payment Schedules • Investigator Payments and Invoices • Study Supplies (Protocols, Amendments, CRFs, CRF Guidelines, Package Inserts, etc.)• Created, maintained, and distributed various study-related spreadsheets, documents, graphs, and reports as required for weekly conference calls, impromptu data requests from Sponsor, Monthly Status Reports, etc.• Overall tracking of screened, enrolled, and randomized subjects. Provided statistics as necessary for monitoring subject statuses (screen fail, enroll fail, early term, completed) as well as discontinuations (AE, withdrew consent, lost to follow up, does not meet I/E criteria, etc.).• Master tracking of all variances (deviations, violations, exemptions) and SAEs (document initial reporting, follow up, IRB notification).• Generated over 2.2 million in investigator payments for IRB, start up, shipping, lab costs, investigator grant payments, etc. from study start up.• Attended Protocol and Therapeutic Training with clinical team; Clinical Administration Foundation Training; Query training.• Served as liaison with monitors, investigative sites and client company personnel.• Performed Master and Investigator file audits.• Filed all study documents. Liaised with Sponsor for end-of-study indexing guidelines.• Maintained, updated, and electronically posted Communication Plan and Master Action Plan

Supervised and coordinated the performance of administrative related business details and client-specific technical support under the general direction of the Director, Strategic Resourcing. This position handled a wide variety of situations and conflicts involving troubleshooting client software and hardware compatibility issues for over 50 home-based CRAs. Management of administrative staff activities necessary to ensure smooth and efficient operation of the departmental office systems and procedures. Over 50 CRAs to be supported in this division for second-line IT issues and client liaison. • Point of contact for client-specific software applications for troubleshooting and resolution.• Created “Listing of IT Issues” spreadsheet to document and track access issues for regional CRAs; documenting trends to facilitate resolution.• Liaised with study team managers, network groups, help desks, Sponsor contacts as appropriate• Software tester for client and company specific software for compatibility.

Provided primary administrative support to supervisor and department; maintained department records and files, travel itineraries and calendars; scheduled and coordinated meetings both internally and externally; compiled data as requested for department reports; point of contact for PPD CRAs for problem resolution and documentation, as well as liaison with SuperUsers concerning information distribution, accessed, connectivity, printing; produced final copy initiation, interim and close-out reports

Major responsibilities included verifying patient eligibility for treatment utilizing Defense Enrollment Eligibility Requirement System (DEERS) and Composite Health Care System (CHCS) for all active duty personnel and family members within command parameters. Performed a variety of receptionist, clerical and record keeping duties associated with patient care and treatment; responsible for a variety of medical services to include appointments, insurance, billing and coding; recorded a variety of physician orders into charts, identifying various chemical compounds, symbols and abbreviations; assembled and filed laboratory results, x-rays, EKGs, and so forth in medical records. Was responsible for training incoming active duty personnel of TRICARE insurance practices; supervised and trained newly hired personnel within direct department.

Was responsible for primary, secondary, and tertiary radio communications for distress/mayday calls; provided secure communications for message and voice traffic via high frequency (HF), ultra high frequency (UHF), very high frequency (VHF) and satellite communications (SATCOM) always maintaining brevity and security; monitored and maintained communications for marine and aviation traffic; performed all general clerical duties, watch standing, and training as required by petty officers.