- Excellent interpersonal, verbal, and written communications with the ability to clearly and persuasively express both my own and other’s ideas
- Self-starter who thrives and succeeds in both independent and team environments
- Flexible thinker with the ability to quickly identify problems and prioritize/organize work goals in a changing environment
- Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
- Excellent ability to handle multiple tasks and many administrative details in a fast-paced and constantly changing environment
Clinical Research Professional (Contractor: Confidential) 4/2009 - Present
- Assist with the preparation and coordination of Investigator Meetings, attend, and present at Investigator meetings as required.
- Participate in study training programs and maintain awareness of developments in relevant field of clinical research.
- Acts as the primary contact for site interactions and communications
- Actively participate in planning, implementing and managing the start-up, execution and closeout activities of assigned studies.
- Ensure the timely and appropriate collection, review and submission of essential documents as required.
- Assist with the development of study manual, monitoring conventions, telephone scripts, tracking forms, and other study related documents.
- Conducts and assists with administrative activities as a member of the project team.
- Perform site management and in house study monitoring tasks for assigned sites
- With the sponsor and project manager, help to ensure optimal selection of Investigators and sites.
- Maintain required study documentation related to site communication and remote site management activities.
- Provide status reports to Project Manager and sponsor as required.
Sr. Clinical Trial Associate II
Confidential, Philadelphia, PA 4/2007 - 3/2009
- Managed administrative support for the clinical project management teams
- Managed the coordination of internal/external meetings including preparing minutes
- Prepared, distributed, collected, reviewed regulatory packets for study start-up and site regulatory document maintenance
- Managed enrollment status spreadsheets, proving weekly status of enrollment vs. starting treatment
- Contacted sites to discuss study-specific forms and document requirements, as well as answering any questions that arise
- Alerted Project Manager of any significant issues at site and assisted with investigator recruitment
Clinical Trial Associate (Contractor)
Confidential, Plymouth Meeting, PA 10/2006 – 4/2007
- Managed over twenty active sites working as part of clinical project management team
- Reviewed regulatory documents received from sites prior to submission to Institutional Review Boards
- Created, populated and maintained the clinical trial monitoring/management tracking system
- Prepared investigator grant payment requests and maintained clinical grant tracking database, generated periodic reports on status of grant payments and resolved payment inquires
Initiation Coordinator, Project Coordinator, Clinical Research Assistant (Contractor)
Confidential, (Sanofi Aventis, Omni Care), Bala Cynwyd, PA 9/2004 – 10/2006
- Provided operational support for delivery of assigned studies on time and within budget
- Provided input in site selection/recruitment processes
- Assisted in preparing and tracking investigational product supplies, packaging, and shipment requests
- Maintained site selection set-up and populated the clinical trial monitoring/management tracking systems
- Assisted in securing necessary drug and non-drug supplies for clinical trials and processed site requests
- Prepared or assisted in the preparation of clinical trial agreements and budget payment schedules
Executive Assistant – Credentialing Dept. (Contractor)
Confidential, Philadelphia, PA 3/2004 – 9/2004
- Provided all levels of administrative and personal support for the Director of Credentialing utilizing the utmost level of integrity and confidentiality; entrusted with security information for both business and home
Executive Assistant - Finance & Group Insurance Department
Confidential, Philadelphia, PA 1/2003 – 2/2004
- Direct administrative support of Vice President, Director of Finance, and Directors
- Tracked expense commitments and actual charges against budget
- Provided heavy calendar and travel assistance, coordinated complex executive meetings
- Prepared reports, spreadsheets, PowerPoint presentations
Bachelor of Science, Health Services Administration
Associate of Art Speech Communications 06/2008
Proficient in MS Office«, Suite 2007 (including ACCESS), MS Windows« XP, Internet Explorer (e.g. Clinicaltrials.gov), Acrobat Professional 7.0., Adobe«, Scanners, Data Projectors, data fax, type 60+ wpm with accuracy, data entry (alpha and numeric) technologically savvy, learn new systems quickly, medical terminology, SharePoint Software, E-Room, Web Portal, EDC (Clinphone), IVRS/IWRS, ECRF, Intercall Software