Karen Wray

Senior Executive Assistant provides comprehensive administrative support to the Dean of the Moody School of Graduate and Advanced Studies and Associate Provost for Graduate Education.

• Extensive scheduling and logistics, preparing agendas, attending meetings, and preparing minutes for meetings of the Dean; arrange travel for the Dean and guests, coordinate interviews for new positions. Assist with the process & preparing for interviewing candidates.
• Building Management Liaison – Maintain and Manage the Moody Hall Building (i.e. STABLE, CCURE “Security”, Inquiries for internal/external of the entire building)
• Schedules and attends meetings on behalf of the Dean for executive building needs.
• Organize workflow of the office, organizing meetings, scheduling, reminders, and catering when necessary.
• Process invoice payments. Oversee timely bill payments and transfer of funds.
• Website updates using Sitecore.
• Support special events for Graduate School (faculty and students), including meetings, receptions, graduation luncheons, and dinners. Oversee final plans for distinguished guests and speaking arrangements for the AVPR and Dean of Graduate Studies. Support and help run "Research Day".
• Supervises Grad Student Workers with day-to-day tasks.

Provided Administrative support to the CEO, and Executive Direct Reports of AccentCare. Performed assigned administraanaged calendar, travel Request and expense Reports.

• Managed calendar, travel Requests, and expense Reports.
• Acted as the point of contact between the CEO, executives, and internal/external clients.
• Received and handled all incoming calls, took messages, and routed correspondence.
• Coordinated All Hands meetings, event planning, and presentation materials for CEO and Executives.
• Received and processed all incoming Invoices Legal to Finance Dept.

Provided administrative support to the Clinical Project Director (CPD), Clinical Project Manager (CPM), CRAs/iCRAs and RSU with preparation. Performed assigned administrative tasks to support team members with clinical trial execution.

• Periodic review of study files for completeness. Electronic Trial Master Files (eTMF) for the study. Collected, reviewed, tracked, and coded essential documents to ensure files are audit-ready on an ongoing basis.
• Updated and uploaded essential clinical trial documents to the following systems and databases: eTMF, ELARA, InnTrax, WIRB, CI, Rightrack II (CTMS), InFORMant/Lotus Notes, SharePoint, SAIRB, ELVIS.
• Updated and generated Sponsor, CRO, and Vendor contact changes within the database systems with the required information.
• Managed and handled the distribution of clinical trial supplies with the maintenance of tracking study inventory information and placing new supply orders.
• Assisted Clinical Research Associates (CRAs)/In-house Clinical Research Associates (iCRA) and Regulatory Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.

• Attended project meetings and assisted project manager with preparation of meeting agenda/minutes when applicable. Calendar management: Coordinating meeting scheduling, drafting meeting agendas, and assisting in preparing PowerPoint slides as needed. Coordinated logistics of study-related meetings including medical expert meetings, investigator meetings, and kick-off meetings. Assists in project travel plans, reservations, and expense reports, specific to meetings wherein they were responsible for logistics.
• Assisted the clinical team in daily study operations which included: (tracking of documents, special projects, and distribution of safety reports.
• Managed Trial Master Files (Paper) and/or (eTMF) ensuring essential documents were filed and audit-ready on an ongoing basis (i.e. collected, reviewed, tracked, and coded). Maintained project-related trackers and provided this information to the study manager.
• Maintained clinical trial management system (CTMS). Creates studies within the system per SOPs, tracks study-specific data, and generates reports.
• Maintained and was responsible for requesting INFORM Training/EDC access for Sponsor, CRO, and Site users to include maintaining and tracking information for each user. Approve users with provided training documentation. Maintain working relationships with vendors weekly on updates/changes.
• Maintained the Confidentiality Agreements (CDA) and Contact Agreement Tracking for New Potential Sites.

• Assisted in project start-up activities including site recruitment and essential study document reviews.
• Managed Trial Master Files to ensure all documentation is complete and audit-ready. Also, eTMF document tracking is managed by the vendor.
• Prepared essential study document binders for site audits as needed.
• Developed and maintained project database to ensure project information is current and available for review, analysis, and reporting.
• Tracked and prepared study-specific information, spreadsheets, and other tools maintained for sponsor electronic study files, utilizing SPS Orion and Access metrics databases.
• Established and maintained relationships with sponsors, investigator sites, and team members to ensure professional, timely, ongoing communication and documentation for each project.
• Attended project meetings, and assisted project manager with meeting action items when applicable.

Supported Project Management - Director, plus a staff of 5 Associate Directors.

• Finance/Budget –Accruals (Responsible for downloading SAP Actuals monthly for the Director of Project Management and each project manager’s program studies).
• Assisted Project Director with Monthly Status Report (gather reports from department heads and compile all information into one summary report).
• Created purchase requisitions using SAP application into database (i.e. contracts, offsite training).
• Tracked and: received invoices - organized, input data into tracking sheet, routed for approvals, and followed up with accounts payable on payment status provided through SAP.

Project Coordination:

• Advisory Board Planning (i.e. Logistics: Travel, Hotel, Transportation, & Catering,
• Preparation for NDA document submission.
• Helped management team with Program Milestone events for King Pharmaceuticals, Inc.
• Set up program logistics for incoming groups (i.e. LCD Projectors, materials, & catering needs.
• Outsourcing to preferred vendors (i.e. docu-source, caters, and marketing companies).

SCIENTIFIC OPERATIONS DEPT. (Kelly Services - Contractor-Temp)

Supported: Respiratory/Dermatology 1 National Director, 3 Therapeutic Directors and 30 Health Care Providers.

• Coordinated Regional support to facilitate general office operations.
• Coordinated/planned logistics with peer leaders for Investigator and PI Board meetings in areas within the US.
• Traveled with Regional investigators and PIs to Investigator & Board meetings three times a year.
• Established communication channels between departments to facilitate efficient work processes.
• Developed, implemented and maintained administrative systems, policies and procedures.

Supported Dept of Pediatrics 2 Directors MD & Pharm.D, 2 Research Faculty Staff, MD, MPH, PhD.

Marketing Events Group:

Supported IMAP Events Group within the MPG/IAG Organization. Supported 3 Senior Level Managers plus 15 individual contributors.