SUMMARY

• A professional with 14 years experience in the pharmaceutical industry. Proven ability to function within a team and as an independent contributor.
• Self - motivated with excellent organizational skills, demonstrated customer focus, and strong interpersonal skills.

TECHNICAL SKILLS:

• Microsoft Office Suite
• Word
• Excel
• SharePoint 2010
• eTMF
• Clinplus 2.1
• Oracle Clinical 3.1

PROFESSIONAL EXPERIENCE:

Confidential, NY

Responsibilities:

• Filing clinical document and maintaining in the TMF
• Tracked and performed quality control of paper documents into TMF
• Prepared and transitioned study documents to long-term archiving facility
• Retrieved study documents from long term facilities when requested
• Administrative duties performed (i.e. photocopying of document, paper file set up, etc.)

Confidential, East Hanover, NJ

Responsibilities:

• Worked closely with IT developers to configure and administer SharePoint Unit Sites
• Enforce standards when implementing sites and sub-sites, along with other features of the environment
• Manage intranet sites built on SharePoint 2010 and support the migration of SharePoint 2007 data
• Worked with MA & CD teams to organize Trial documents per defined folder structures in SharePoint 2010
• Administered and maintained sites and sub-sites, site and system security along with structure and content
• Created folder structures as required and migrated documents on shared drive into SharePoint 2010
• Reconciliation of documentation and ensured that documents were available for every trial
• Support system to Clinical Trial teams in navigating through SharePoint
• Delegated access on different levels, roles, responsibilities within SharePoint 2010

Confidential, NJ

Clinical Research Specialist (Contract) (Global Health Outcomes)

Responsibilities:

• Perform denied parties screenings of individuals list in the FCPA and Compliance Checks
• Provided documentation of the results of the screenings to GMAx manager
• Review, identify and resolve all Due Diligence Red Flags and Denied Parties Screening Matches
• Perform denied party screenings of individuals listed on Compliance and FCPA Checks
• Queried, reconciled, updated and ensure compliance with policies and procedures in OIG, EPLS and OFAC results in SAP Database to manager
• Review, identify and resolve all FCPA and denied parties screening matches
• Provide vendors with copy of the appropriate SOP’s and the FCPA training materials
• Assisted senior staff in supporting activities, related to reporting requirements of observational studies
• Maintained databases of observational studies to ensure compliance with reporting requirements
• Liaison between study research teams in Clinical Trials
• Identified, requested and ensured delivery of FCPA issues

Confidential

Document Assistant/ Administrative Assistant

Responsibilities:

• Supported the Investigator Document Assistant (IDA)
• Filing essential documents and maintenance of the TMF
• Retrieved study documents from long term facilities when requested
• Renamed, filed electronic documents in eTMF system, faxed, scanned documents into electronic format prior to importing, ICF's, 1572’s, Financial Disclosure forms, CLIA, Amendments, Deviations, IB’s etc.
• Excel tracker sheet communication between managers
• Performed visual quality checks of e-documents prior to import to confirm image clarity and readability
• At the end of studies review study files for organization, reconciliation for accuracy, completeness
• Assisted with the maintenance of complex study files per SOPs
• Administrative duties (i.e. photocopying of documents, paper file set up, etc.)

Confidential, NJ

Scanner/Indexer (Contract)

Responsibilities:

• Received and QC’d CRF’s for completeness
• Scheduled video conferences
• Created instruction manuals for CRF scanning/indexing process
• Collaborated closely with International customers/to resolve DE issues
• Trained new hires on the scanning/indexing process
• Ensured receipt of all patient-specific case report forms
• Audit source documents for quality and legibility prior to submission to Clinical Document Warehouse
• Determined if any documents required translation; forwarded documents to appropriate parties
• Reviewed source documents for violations of HIPAA guidelines
• Executed corrections to source documents according to GCP guidelines
• Performed second key entry and data cleanup
• Validated database information for clinical drug studies
• Created user instructions documents
• Generated and resolved edit checks and manual queries

Confidential, NJ

Clinical Data Entry Operator Consultant (Contract)

Responsibilities:

• Assisted with updating and verifying clinical data, resolving data discrepancies and other related issues
• Reviewed and updated data in Oracle Clinical Database and identified data entry problems and errors
• Performed data entry screen testing
• Reconciled and reviewed first and second pass data entry
• Set up patient and investigator information
• Interacted with clinical data coordinators to negotiate project timelines
• Reviewed data listings for verification
• UAT Testing
• Reviewed discrepancy database, generated query of DCFs and audited various studies
• Assisted with filing of case report forms and utilized Oracle Clinical and SAS