PROFESSIONAL EXPERIENCE:

Confidential

Regulatory Affairs Operations Documentation Specialist

Responsibilities:

• Responsible for the management and maintenance of regulatory submissions documents. Proficient in management of paper and electronic documents.
• Responsible for management of paper and electronic regulatory documentation.
• Organize, pack, ship and track records for scanning or off - site storage. Inventory and create logs or track spreadsheets for regulatory submissions. Organize files, scan, retrieve and distribute regulated records, as needed; Upload and electronically file scanned documents, using document management systems and following file naming conventions. May need to fulfill requests for specific documents for regulatory team members.

Confidential

Document Management Specialist, Document Processing Center (DPC)

Responsibilities:

• Processed and maintained electronic and paper clinical trial documentation.
• Supported project teams initiatives with, filing, scanning, and archiving.
• Identified and resolved documentation discrepancies with various departments.
• Reviewed, reconciled, and processed transmittal form packages.
• Performed quality control (QC) review of internal trial master files (TMF).
• Performed all functions related to DPC Scanning Solution/electronic TMF including scanning, image QC, indexing and index QC.
• Acted as central contact for clinical teams and vendors for designated project communications, correspondence, and associated documentation.
• Provided resolutions to clinical teams with document transmittal discrepancies.
• Created labels, folders, binders and prepared work area for customers.
• Maintained the integrity of the DPC and the file room (room access, closure, shelf organization, etc.).
• Maintained and tracked common area files (safety letters, IB’s, etc.).
• Created Trial Master File tracking system for (TMF) documents in preparation for archiving.
• Orchestrated and verified requests for off-site storage as well as assemble and package boxes for transfer (approximately 20lbs) to the DPC. Assign and track DPC box numbering system.
• Maintained off site archiving facility documentation. Performed data entry and data verification.
• Notified off site archiving facility of departmental pickup and delivery status.

Confidential

Document Regulatory Associate

Responsibilities:

• Performed system administration activities required to properly initiate and closeout study sites or studies in phase 2 through 4 clinical trials.
• Responsible for accurately updating and maintaining clinical systems (CTMS) that track site compliance and performance within project timelines.
• Performed manual data entry into the Clinical Trial Management System (CTMS), TMF, case report form (CRF) imaging and various departmental databases.
• Monitored/tracked appropriate documentation to meet contracted and agreed upon system review timelines.
• Maintained weekly document processing metrics.
• Ensured consistent receipt analysis, classification, and registration of hardcopy and electronic clinical trial documents.
• Performed QC checks of regulatory documents.
• Knowledge of clinical operation standard operating procedure (SOP) for attribution of documents.

Confidential

Clinical Documentation Specialist

Responsibilities:

• Responsible for identification of Trial Master Files (TMF’s) submitted to the central file for various therapeutic area’s for Oncology, Anti-infective, Cardiovascular, Allergy and Dermatology; classified and attributed TMF’s appropriately using a sophisticated ORACLE-based system (Clinical Documentation Information Tracking System Documentum).
• Reviewed TMF’s for accuracy, completeness, and consistency. Identified discrepancies and followed-up accordingly.
• Independently categorized all incoming clinical study documentation (i.e. CRF’s, Protocols, Investigator Visit Reports, CV’s, IRB/EC documentation, FDA 1572 forms, Investigator Brochures, Statistical Reports, Regulatory Documentation, Financial s, Laboratory s/Ranges, SUSAR notifications etc.).
• Ensured documents were in compliance and in adherence to SOP and GCP/GDP guidelines.
• Assisted in the electronic preparation of CRF’s for FDA submissions, including case report form templates and discrepancy reports.
• Actively arranged and uphold CRF database for various FDA submissions. Compiled information and provided daily submission status updates/reports to management.
• Preserved effective relationships and collaborated with HQ contacts, CRO’s and other members of the clinical operations team to resolve study related-document inquiries to ensure fast document acceptance.
• Conducted database searches, provided reports and information as requested by clients; Prepared audits for requested studies for clinical Research/Global Regulatory Affairs and completed Master File Reconciliations.
• Maintained the organization of received clinical study documentation to allow my therapy group to meet client requests efficiently and promptly.
• Distinguished and evaluated potential document errors and actively used proper guidelines to correct inaccuracies for document acceptance.
• Trained and closely mentored new group members in all aspects of clinical indexing, handling client requests and submissions.
• Supported new members by fostering an encouraging approach, modified according to their needs/ levels and provided resources.