• Oversees study startup and ensures the TMF is complete at the time of study closeout or submission for multiple studies. • Maintains eTMF studies documentation and ensures eTMF specifications are compliant and consistent with client standard and regulatory requirements/guidance. • Monitors completeness, timeliness, and quality of content for multiple studies, including documents within the QC lifecycle as well as reconciliation of documents already finalized. • Communicates the Timeliness and Quality Metric reports to the Partners and Client weekly. • Processing of Approved List Change and QC Tasks within multiple studies daily. • Point of Contact person with the Partner and the Client, attending TMF Health meetings for multiple studies via monthly TMF Health meetings. • Identifies any trends regarding potential issues affecting metrics and communicates findings to the Study Owner Team Lead and the Partners and Client. • Serves as a point of contact with the Partners and Client for internal and external audits/inspections of studies. • Working with the Study Owner Team Lead, acts as the eTMF SME with the Partners and the Client and for the study teams regarding questions on how the eTMF functions and/or how to better use the eTMF to enhance the eTMF experience.• Works with a team of Document Specialists, communicating any training issues and trends negatively impacting TMF metrics daily. • Works with a team of Partner Document Submitters for multiple studies, communicating any training issues and trends negatively impacting TMF metrics daily.

• Responsible for processing eTMF documents and performing QC review in accordance with SOPs, work instructions, ICH GCP guidelines, eTMF reference model and study specific eTMF plans.• Given the additional responsibility of a document QC person, ensuring that all corrections and changes made to documents were done correctly per client requests, and also given the additional responsibility of directly helping Team Lead with all requested tasks as her own job duties increased including: Training the Offshore eTMF team in Kochi, India, by attending upskilling meetings and taking and distributing meeting minutes Helped the Team Lead in authoring and editing process documents from beginning to completion Primary contact person for answering all document queries for both on and offshore team members, answering queries within a 24-hour window to ensure timely completion of file reviews• Help with End of Month Procedures ensuring all file reviews are completed by the Client deadline, and as promised.• Conduct 100% quality check on documents in database to identify errors• Use Good Document Practices to correct data (self-evident corrections)• Delegate documents to Document Owners for review of errors identified• Maintain quality and timeliness for full completion of all documents within the specified review window• Inform manager of training issues, project activities, quality issues and timelines as directed.• Create file reviews as requested• Review paper transmittals from the client for accuracy before uploading documents into the eTMF• Indexing documents and primary Indexing QC person as requested, ensuring all documents indexed have been indexed correctly to catch errors and correct prior to documents reaching file review. • Send all the reviewed/completed file reviews to the client, Biogen, weekly for accurate document billing purposes• Act as a resource with other team members, answering document questions, and helping with Ad Hoc training

Supported the Branch Office Manager, the Branch Compliance Officer and five financial advisors in the practice performing all client service and administrative duties. Heavy client interface acting as receptionist, answering and directing all incoming phone calls, and greeting all incoming clients, wholesalers, and vendors.

Supported Management using Microsoft Office 365, Outlook calendar, travel reservations, scheduled, set up company meetings and events, prepared proposals and reports using Publisher and PowerPoint.

Supported the Company's Top Investment Specialist, and Top Producing Annuity and Life Insurance Representative. Prepared investment paperwork, monitored new business processing using Salesforce CRM to track workflows, kept client files organized. Worked with Broker/Dealer in back office: client onboarding, asset transfers, etc.

Assisted Branch Manager, Sales & Client Services Supervisor and Account Managers in all areas of administrative support. Heavy concentration on making outbound customer service phone calls to follow-up outstanding paperwork and assisting customers in obtaining necessary documents. Accepted premium payments.

Reported directly to the Vice President and assisted the Clinical Review Coordinators (three nurses and one doctor) in all aspects of case review, prepared case processing forms, transcribed peer clinical reviewer determination forms. Managed the triage area for all incoming cases. Initial point of contact for clients and physicians. .

Provided administrative support to the Program Director for Outpatient Services for three locations assisting with a number of varied and diverse duties as requested.

Supported several Drug Information Association departments with various administrative and customer service duties.

Supported owners and two paralegals with all administrative duties. Responsible for entering, handling and dealing with healthcare subrogation cases from initial onset of acquiring the case and all follow up with clients (healthcare administrators) and plan members and lawyers to the final stage of settling the case. Used SAGE ACT, a database program like Access for logging all follow up for all subrogation cases. Handled all the accounting functions for the Company Trust and Operating Accounts using QuickBooks.

Updated and maintained master proposal database, active project database, and company contact database (added over 300 new contacts). Negotiated a new water contract with Deer Park Water, greatly reducing the cost of the current water and coffee service for the Company. Negotiated a new trash service contract with J. P. Mascaro, upgrading the Company's existing trash pickup service.

Administrative Assistant and Travel Coordinator, February 2011 to November 2011Primary responsibility was as the Corporate Travel Coordinator. Set up all travel arrangements for all employees including the Executive Leadership Team.

Provided all administrative support to the President, Sales Manager, and IT Manager. Used QuickBooks Pro for entering invoices and purchase orders and for reconciling Company bank, credit card, and PayPal accounts.

• Provided all administrative support to the President and CEO, the Vice President of Sales and Marketing and outside sales force, the Vice President of Manufacturing and the Plant Manager and Plant Foremen• Handled all human resource functions for the Company including:• Processing all new hire applications• New hire background checks• New hire orientation• Payroll for both hourly (weekly) and salaried (bi-monthly) employees via ADP Payroll Solutions• Administered employee benefits when time appropriate• Reconciled customer accounts• Processed and approved new customer credit applications• Set up an invoicing system for the Company to better manage their invoices and receivables where there was previously none in place• Maintained and ordered all company supplies for both the office and the manufacturing plant• Processed and sent out monthly statements for all customers• Set up and maintained filing system for all company customer and vendor accounts where there was previously none in place• Set up a purchase order system for the Company where there was previously none in place• Matched up all company purchase orders and packing slips with vendor invoices for accurate and timely payment• Processed customer orders for pickup and delivery coordinating with the outside sales force, customers and various trucking companies• Processed all incoming customer payments• Left this position to return to college full time pursuing a Business Admin Associates Degree

Provided all administrative support to the owner and inside sales force for the Company• Reconciled customer accounts• Processed and approved new customer credit applications• Provided accounts receivable references on current customers for other companies looking to extend credit• Responsible for implementing a working invoicing and statement system within Excel to better manage the Company’s invoices and receivables where there was previously none in place• Responsible for setting up company on-line account for ordering and maintaining all company supplies• Responsible for implementing a monthly statement system for a customer base of roughly 600 customers where there was previously none in place• Set up and maintained filing system for all company customer and vendor accounts, payables and receivables where there was previously none in place• Set up a purchase order system for the Company where there was previously none in place• Matched up and proofed all company purchase orders and packing slips with vendor invoices for accurate and timely payment• Processed customer orders for pickup and delivery• Processed all incoming customer payments• Authored routine company correspondence as requested and required

• Reconciled multiple bank accounts and multiple customer accounts• Processed and approved new customer credit applications• Attended monthly A/R and A/P Manager’s meetings• Checked and evaluated personal and corporate credit histories via Dun & Bradstreet online• Provided accounts receivable references on customers for other companies• Coordinated with lawyers and collection agencies regarding delinquent accounts• Analyzed accounts receivable/payable long and short aging reports• Supervised monthly and yearly accounts receivable/payable closings• Attended accounts receivable seminars as necessary• Interacted daily with vendors and employees to research and resolve receivables’ inquiries anddiscrepancies• Interacted with internal and external auditors and participated in occasional auditing projects to provideinformation and access to company accounting records as required• Authored routine company correspondence as requested and required

Managed all office functions including accounting and payroll functions using QuickBooks Pro,QuickBooks Online Edition and ADP Payroll Solutions online• Greeted all customers calling into and coming into the shop including scheduling all initial and follow-upappointments when time appropriate• Supported the Owner/President and Service Manager with general administrative and personal dutiesincluding:• Setting up all bills for on-line payment and monitoring• Keeping track of all employee information• Answering and screening phone calls• Making deposits and reconciling company bank accounts on a daily basis• Inputting and proofing data for daily job tickets for invoicing customers• Paying all company bills• Monthly statement reconciliation with vendor invoices• Company payroll and coordinating payroll tax information• Typing correspondence• Travel and calendar arrangements• Making local deliveries• Managing employee benefit packages• Keeping inventory of all necessary company supplies, both shop and office related

This position was the foundation for all functions of the Hickman, an assisted living retirement community• Reported directly to the Business Manager handling all billing, accounts payable and receivable functions for the facility using QuickBooks• Administratively supported all Department Heads (Public Relations, Admissions, Information Systems, Activities, Dietary, Resident Care, Development and the Facility Director) as well as acting as front office receptionist, greeting all incoming visitors and answering all incoming phone lines• Primary focus entailed taking care of all Hickman resident (180 at the time) concerns quickly, efficiently and courteously• Extremely busy, high volume job with the need to be flexible, detail oriented, organized and able to prioritize multiple tasks literally minute to minute

Performed all general administrative support duties for the Practice Manager of the Manufacturing,Distribution and Retail Practice within the Consulting and Systems Integration Department and his five Account Executives including:• Typing correspondence; travel arrangements; daily calendar management and attendance records for the MDR Practice• Served as the primary contact person for the outside sales force and as the primary liaison between outside clients, both new and established, and the Practice Manager• Responsible for setting up project and staffing profiles for each individual project and for the invoicing of clients, making sure that invoices were sent out error free and in a timely manner

General customer service duties including:• Taking customer calls• Trouble shooting• Entering customer orders• Expediting work orders for material• Quoting price and delivery• Assisting customers with technical product knowledge• Cross referencing part numbers and drawings• Calculating gross profit for special quotes• Tracking shipments upon customer request• Responsible for handling all foreign paperwork necessary for material being shipped to customers outside of the United States• Typing export declarations, certificates of origin, harmonized tariff codes and coordinating proper shipping methods with the Traffic Manager• Provided administrative support to the Sales Manager• Primary contact person for all international customers

From March of 1993 through February of 1994, I was Executive Assistant to the Manager of Staff Function Systems within the Information Systems Department.• Performed all secretarial functions including:• Graphics for displays and presentations• Typing correspondence• All human resources functions for the Staff Function Systems Department• Handling the phones and making travel arrangementsFrom May of 1988 through March of 1993, I performed all administrative duties for the General Manager and the Rooms Operations Manager of the Hotel du Pont• Extremely heavy and diverse workload with the need to perform many different tasks simultaneously while also attending to customer needs in an efficient, courteous and professional manner• Authored routine and customer correspondence and performed all duties with essentially no supervision