| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
Street Address Buchanan Drive
Gurnee, IL Street Address
PHONE NUMBER AVAILABLE
EMAIL AVAILABLE
CAREER PROFILE
Experienced and energetic clinical support professional with strong focus on accuracy and on-time performance. Extensive regulatory knowledge and expertise with a broad array of clinical database software. Proven ability to form strong working relationships with colleagues as well as outside parties.
EXPERIENCE
ABBOTT LABORATORIES Waukegan, IL Sep 2012- Present
Contractor through Experis
Clinical Document Specialist II
Receive/retrieve documents from the Clinical Research Specialist (CRS), Clinical Study Assistant (CSA) and/or Clinical Research Organizations (CRO s)
Manage Trial Master File (TMF) ensuring files are correct, complete, and consistent with Abbott SOP s and regulatory requirements.
Create content for Clinical Study Report (CSR) appendices.
Ensure subject identifying information is deleted from essential document received.
Provide accurate progress reports on collection of study-specific documentation.
Scan, bookmark, and upload documents into eDocs.
Ensure scanned documents are available for author/Medical Writing review per study timelines.
Manage and archive paper Case Report Forms (CRF s).
LUNDBECK, INC. (formerly Ovation Pharmaceuticals, Inc.) Deerfield, IL 2007 2012
Clinical Support Coordinator
Reviewed all essential documents/contracts to ensure completeness, accuracy and compliance with applicable company SOP s, regulatory and FDA requirements.
Coordinated and ensured the timely collection, maintenance, filing, and tracking of study documentation in keeping with established timelines.
Liaised with Contract Research Organizations (CRO s) in the collection of study-specific documentation necessary for timely drug release.
Performed ongoing literature support activities such as: requests, acquisition, translation, and filing as well as maintenance of literature reference database
Provided accurate progress reports on collection of study-specific documentation.
Scanned, and upload documents into Documentum.
TAKEDA GLOBAL RESEARCH AND DEVELOPMENT INC. (TGRD) Deerfield, IL 2004 2007
Contractor through Delta Pharma
Correspondence Clerk
Reviewed site documents and internal documents to ensure quality and accuracy per TGRD standards.
Assisted with tracking of documents from Takeda Japanese headquarters, Takeda Europe, CRO s and investigator sites through completion of internal processes prior to filing.
Performed Quality Checks on documents received from Takeda Japanese Headquarters, Takeda Europe, and outside vendors.
Catalogued and filed essential documents, site documentation and internal documents per TGRD guidelines.
Researched and compiled essential documents for audits and clinical operations.
Interacted with Study Managers regarding required documents needed for Trial Master File.
Maintained Document Management Center file room.
Compiled and verified documents prior to archival of trial-related materials to off-site storage facility.
Scanned and uploaded documents into Documentum.
ESSENTIAL GROUP (formerly AmericasDoctor) Gurnee, IL 2001- 2004
Project Support Specialist
Completed regulatory documents, and sent to clinical sites (for investigator review and agreement and /or acknowledgment of receipt).
Tracked regulatory study documents in an Access database, and collected completed regulatory documents from clinical sites.
Successfully managed global change project for FDA Form 1572 s
Assessed clinical site study documentation for completeness and compliance with regulatory requirements and guidelines.
Prepared and submitted FDA Form 1572s, IND Safety Reports and other documents to central and local Institutional Review Boards (IRB s) on behalf of sites and according to project time lines.
Coordinated the resolution of issues between clinical sites, project managers, sponsors and IRB s.
Continually monitored ICH Guidelines and the Code of Federal Regulations (including Good Clinical Practice) as they apply to regulatory document processing.
EDUCATION
College of Lake County Grayslake, IL Associate of Science 1993
|
