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Technical Documentation Operations Specialist Resume

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New, JerseY

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PROFESSIONAL EXPERIENCE

Confidential, New Jersey

Technical Documentation Operations Specialist

Responsibilities:

  • Accountable for demonstrating familiarity with and all operational aspects of assigned Confidential Research Laboratories (MRL) Phase II - IV clinical trials.
  • Perform manual data entry in Clinical Trails Management Systems (CTMS), Trail Master File (TMF), CRF Imaging and several of other systems.
  • Demonstrate technical skills required to navigate/access other authoritative sources/shared reference data required for reporting/information/searching of clinical and regulatory document.
  • Process clinical trial regulatory, clinical, and financial documents within 24/72 hours as specified by document type according to priority; utilize document management system to support batching, scanning, importing, indexing, and rework as required or as needed to maintain accurate/complete files.
  • Ensure timely data entry to meet customer specifications and thereby support identified business processes.
  • Configure/create/monitor/update initiation/regulatory/close-out package and other related packages
  • Perform all functions related to the Document Package Analysis Procedures and be able to locate/upload required documents for primary investigator's accessibility through the CPAC portal.
  • Compile and distribute administrative binders hardcopy and/or via the portal.
  • Be knowledgeable of regulatory document types, subtypes, and units as per document procedures; redirect documents as required.
  • Communicate with sites, Clinical Research Associate, Patient Informed Consent Specialists, Medical Program Financial Specialist, Clinical Operations Specialist, IRBs and outside vendors regarding study documentation and study database on a daily bases regarding the progress and completion of data entry activities
  • Demonstrated leadership skills with ability to create and work in high performance teams and/or matrix organization.
  • Demonstrate expertise and depth of knowledge with Clinical Trial Management Systems.

Contractor

Confidential, New Jersey

Responsibilities:

  • Maintain and provide all "Essential" Clinical Trial documents and be able to interact with Clinical, Regulatory, and Financial regarding the receipt, analysis, classification and disposition of these documents.
  • Provide process improvement recommendations to Clinical Quality & Compliance Manager.
  • Demonstrate familiarity with the clinical trial process in order to enter and extract pertinent information required for report generation.
  • Ensure that ICH, FDA, EU directives and any other regulatory requirements, as applicable, are being considered during procedural document development by participating on procedural document workgroups or reviewing procedural documents.
  • Provide prompt feedback to functional areas on issues regarding the receipt, analysis, classification, and disposition/filing/retrieval of hard copy and electronic documents in conjunction with the supervisor(s).
  • Maintain weekly document processing metrics/errors/returns for department.
  • Liaise with functional areas as required for the collection and analysis of compliance reports/documents.
  • Assisted in conducting Quality Compliance reviews of submission documents as assigned.

TECHNICAL SKILLS

Operating Environment: DOS, UNIX System V Solaris, Windows 95, 98, NT, 2000, and XP, Mac7.3.3, Mac OS 8,9

Spreadsheet Software: Excel 5.0, Lotus 1-2-3

Word Processing: Microsoft Word 2000, Word Perfect, Corel Word Perfect 6.0 & 8.0, MacWrite and Claris 3.0

Applications: UPS World ship, Norton Utilities, Sam Virus, and Avery Labeling

Application Tools: Microsoft Office Project 2003, Oracle Developer Tool, Oracle Reports, Oracle Forms, and LAPLINK

Database: Oracle 9i, 7, 8, File Maker Pro 3.0, 4.0, Microsoft Access Database Business Tool, and Oracle Discoverer 3.0 Administrator Tool, Documentum, First Doc, CTMS IMPACT

Internet: Telnet, Gopher, Netscape Navigator, Mozilla-Firefox 1.5.0.4, Netscape Communicator, Eudora Reznet, Fetch, Tin Can, FTP, Secure CRT

Calendar Tool: Microsoft Outlook, Netscape Calendar, Lotus Notes, and Oracle

Email Tool: Microsoft Outlook, Mozilla Thunderbird

Honors/Awards: New Jersey Nets and Devils Scholarship, Pell/Tag Grants, Academic Achievement 03’, Dean’s List Spring 04’, NJCU Alumni Association

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