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- 1. FELICIA D. PHILLIPS 5791 Dunlap Street * Philadelphia, PA 19131 * (215) 871-0153 * Email: fdphillips2@msn.com EDUCATION Peirce College, Philadelphia, PA – Bachelor of Science, Major: Business Administration/Management 2007 Peirce College, Philadelphia, PA –A.S., Micro Computing, 1998 RELATED PROFESSIONALEXPERIENCE PRA HealthSciences September 2013-In House Clinical Research Associate Provide initial support to Local Trial Manager by distributing and tracking of regulatory documents for accuracy and completeness.  Performs investigator recruitment activities and evaluate investigative sites.  Utilizes the Clinical Trial Management system (CTMS) to ensure investigator recruitment activities are accurately tracked.  Performs essential document collection, review, maintenance and close-out activities, ensuring that Sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/CGP guidelines.  Supports investigators and investigative staff in fulfilling obligations with regard to local Submissions according to local regulatory and Institution Review Board (IRB)/independent Ethics Committee (IEC) requirements.  Performs study tracking via CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.  Documents site and Sponsor contact and study interactions in a timely and professional manner.  Assists with resolution of investigational site/data queries.  Liaises with project team members regarding study site issues.  Provides quality review of the informed consent template.  Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study. Research Pharmaceutical Services, Inc. Fort Washington, PA, USA January 2011-September2013 Clinical Trial Associate  Contact potential investigators for participation in clinical trials, distribute questionnaires, and track responses.  Check debarment websites, including SAM and OIG and OHRP databases to ensure potential investigators and institutions are not excluded and to ensure and IRBs are registered.  Run reports to ensure consistent filing in eTMF and accurate data entry in CTMS.  Prepare study start-up regulatory binders for investigational sites.  Track Financial Disclosures, Form FDA 1572s, Protocol/Amendment Signature Pages, and Site Contacts in the CTMS system.  Create and maintain Investigator Files; review files quarterly to ensure all documents received and properly filed.  Track documents on Trial Master Spreadsheet and file electronic documents in the eTMF system.  Provide general administrative support, including copying, scanning, and mass mailings.  Assist with special projects including working with the Pilot program for the new administrative support role, mentoring new hires, assisting with the migration of SharePoint documents, and other projects as assigned by manager. GlaxoSmithKline (GSK) (Contract) 6/10-1/2011 Clinical Study Associate Provide operational support for delivery of assigned studies or programs on time and within budget through both internal and external sourcing strategies.  Review required regulatory documents from study sites for quality and accuracy  Track receipt of regulatory documents from study sites and submit to appropriate departments for approval of drug shipment  Interact with sites to resolve regulatory and financial document discrepancies  Assist in reporting and tracking of study budget spend, including processing study invoices  Order, assemble, distribute, manage and track inventory of study conduct tools and non-drug clinical supplies  Maintain study/site information in GSK database systems  Coordinate mass mailings/faxes to study sites
- 2. Children’s Hospital of Philadelphia 3/08- 11/ 2009 Clinical Research Coordinator(Contract) Responsible for the coordination of clinical research activities conducted within the CHOP healthcare network.  Worked within the scope of clinical research protocols, participates in research activities which may include: subject recruitment, confirmation of subject eligibility, informed consent process, completion of case report forms, data clarification, IRB preparations, chart abstraction, hosting monitor visits, organizing site initiation visits  Meet enrollment projections within study-specified times  Hosted in-services on floors independently  Adhered to policy and procedures surrounding IRB, FDA, ICH, and GCP processes  Reviewed and consent patients to various studies such as; Lupus and Bone Density  Ensured patient eligibility in regards inclusion/exclusion to study protocol requirements  Reviewed the importance of calcium and vitamin D for bone and growth structure Clinsys Clinical Research, Inc. 1/07 – 3/08, Clinical Trial Associate Perform as the primary coordinator for all aspect of assigned trials.  Interact directly with multiple study vendors to order and distribute clinical supplies to include Case Report Forms, Laboratory supplies, and data management vendors  Prepare FDA-required regulatory submissions to the Central Institutional Review Board  Review regulatory documents prior to approval  Assist with Quality Control review of the files according to applicable Sops  Assist with the training of new employees  Attend team teleconferences Wyeth Pharmaceuticals 2/06 – 1/07, Clinical Study Date Coordinator(Contract) Updated approved studies into Clinical database in IMPACT/IMPACT Hercules, utilizing approved Early Clinical Plan (ECP), Late Clinical Plan (LCP) provided by the CRC Coordinator.  Enter preliminary information for old/new studies.  Responsible for initiating process to obtain dates/data to be entered into database.  Generate reports from the database as required or requested.  Corresponds with Clinical Portfolio Management staff and management informed of status of date/data entry and any issues related to updating the database.  Establish and maintains professional and productive working relationships within GCCAP, CTO and Clinical Research.  Reviews and updates procedures for all tasks involved and offer suggestions for improvements in workflow and procedures.  Participate with interdepartmental teams to revise or develop company-wide Clinical database procedures. Children’s Hospital of Philadelphia 7/04 – 8/05, Clinical Trial Associate Assist Clinical Trial Managers and CRAs with various duties for the Clinical Operations Department  Processed CDAs  Assisted in Investigator Meetings.  Distribution of protocol, ICFs and Financial Disclosure Forms to sites.  Collected and reviewed regulatory documents.  Assisted sites with preparation of regulatory documents and IRB submissions  Served as a resource to sites for study related inquiries  Shipped study supplies to sites  Maintained master files.  Collected screening enrollment logs.  Complied with GCP/ICH guidelines. PROFESSIONAL TRAINING  Drug Information Association (DIA) Drug Information Association (DIA) Drug Development for Administrative Staff Fundamentals of Clinical Research Monitoring COMPUTER SKILLS  Windows XP, Microsoft Office 2000, Trial Works/IMPACT Hercules Database, FileMaker Pro, Lotus Notes DB, Intralinks, Business Objects, CTSRS, CTMS, eTMF THERAUPUETIC AREAS  Bladder Control, Diabetes, Epilepsy, Oncology, Rheumatology