Highly motivated professional with demonstrated skills in problem solving, planning/organizing, quality control, adaptability and dependability. Able to establish priorities and multi-task while adhering to deadlines. Trusted to maintain confidentiality of sensitive information. Experience with Clinical Trial documents and Protocol preparation. SOP preparation, streamlining of procedures and updated current Good Manufacturing Practices. Accustomed to working with Project and Regulatory Team. Highly motivated team player with critical thinking, problem solving, interpersonal, communication, analytical, and organizational skills. Proficient in the use of major software programs, including Documentum, Microsoft Office Professional, Word, Excel, Access, Power Point, Publisher, Outlook/GroupWise, Lotus Notes, Quark X Press, Photoshop, Dreamwaver, Illustrator, Flash, Visio, web pages, and the Internet. Marketing background: Pharmaceutical/Clinical R&D, Real Estate, and Design/Architecture related industries.
Professional Experience:September ••••• to January ••••• (Contract)CSL Behring/Aerotek Inc., King of Prussia, •••••ical Document Coordinator, Clinical Research & Development Contracted alongside a project management team to develop global regulatory submission documents. Successfully recruited Investigators for the Beriplex P/N Clinical Trial when an outside CRO was unsuccessful. Tracked Confidentiality and Non-Disclosure Agreements and other study related materials. Participated in clinical operations initiatives and programs as assigned. Reviewed and formatted documents. Reviewed Protocols, Power Point presentations and study materials according to productivity targets. Compose and format newsletter-using •••••h ••••• to July •••••Merck & Co. Inc./ClinForce, Ambler, •••••ical Document Coordinator (Contract)Assisted twenty Patient Informed Consent Specialists and Program Manager Ensured regulatory documents were collected, reviewed, and archived in compliance with SOPs, GCP, and ICH/FDA regulations to support Merck & Co.s clinical research. Responsible for all meeting minutes relating to Patient Informed Consent and the Regulatory processes. Experienced with the terminology related to medical and the Regulatory processes. Coordinated and planned interview schedules and maintained daily department •••••ember ••••• to February •••••Omnicare Clinical Research, King of Prussia, •••••ical Assistant, Biometrics Department Generate and maintain study specific tracking data, and program records for drug submissions to the FDA. Worked to set-up SAP programming, charts, and graphs in order to support trial related drug submissions. Supported Vice President and Department of Statisticians and •••••ary ••••• March ••••• (Contract)InterDigital Communications Co. Legal Assistant Supported 2 attorneys; Assistant Deputy General Council and an Immigration Lawyer. Maintained file and processed paperwork for immigration, Visa and passports The General Council reported to the Corporation Board. I maintained Meeting Minutes, Stock purchases records and ••••• ••••• January •••••Ambler Care Pharmacy formerly Omnicare, •••••lb Pike, Blue Bell, •••••utive Assistant to the Director of Pharmacy/Executive Director Supported Director of Pharmacy/Executive Director in day-to-day operations of a large institutional pharmacy. Designed the layout of marketing materials Wrote and formatted proposals, tracked monthly drug reports and sales data Coordinate pharmaceutical speaker presentations, meeting and advertising materials. Human Resource responsibility for HIPPA, Compliance training, and interview scheduling. Set-up new computers and updated software on PCs. Handle drug recalls, price checks, and cost accounting •••••ember ••••• March •••••PharmaNet, Inc., Blue Bell, •••••or Technical Assistant, Oncology Division Provide administrative support to the Assistant Director and his team. Formatted, edited wording for study materials and other documents which were sent to the sites at start-up. Set-up and maintain project files, Investigator files and their payments. Tracked contact information using Excel for ••••• Clinical Trial Sites. Wrote, edited and maintain study-specific tracking spreadsheets, and documentation. Sent documentation to clients regarding the Investigators, Institutional Review Boards (IRBs), and Adverse Event Reports. Prepare Regulatory Binders, Study File Notebooks, Investigators meeting minutes, and monthly Newsletter. Created and prepare study related graphics, pocket handouts, and Dose Modification •••••ract Assignments:March ••••• February •••••June ••••• September •••••Alan Pharmaceutical, Horsham, PA. Assisted the President with pharmaceutical submissions. Typed the product package inserts, which were submitted to the FDA along with other office •••••l ••••• June •••••P. K. Mitra Engineering, Fort Washington, PA. Mr. Mitra was writing a Calculus and structural engineering book. With my background in Architecture I was able to follow the thought process and do his structural ••••• ••••• August •••••Kessler Rehabilitation Services, Horsham, •••••stant in the Human Resource Department Human Resource Department - Worked for manager of the Mid-Atlantic Region. Assisted with background testing, reports and preparation of marketing materials for the region. Designed multi-state marketing mailer that successfully attracted physical therapists to fill openings within the company. This saved significant advertising ••••• ••••• August •••••Glaxo-SmithKlein, River Road, Conshohocken, •••••nistrative Assistant to the Assistant Director of the Quality Control Department. Handled the Quality Assurance Department needs for a group of Biologists. Maintained Human Resources records for the department along with vacation and other benefit reports. Arranged functions, meetings, travel and •••••st ••••• February •••••USFilter, Chalfont, •••••nistrative Assistant/Proposal Writer Wrote and edited proposals and presentations of products Creation and maintenance of their sales and marketing presentation material. Completed brochures along with burning CDs when needed
Education:Kriger Research Group International Management & Marketing in the Pharmaceutical Industry Completion date January •••••ciate Degree Multimedia Web Program The Art Institute of Philadelphia, •••••ciate of Applied Sciences Digital Design & Marketing Montgomery Co. Community College, Blue Bell, •••••elor of Science Architecture/Interior Design & Marketing, Philadelphia University, Philadelphia, PA.
Clinical Trial Assistant