SUMMARY:

• Dedicated and dependable Pharmaceutical Document Specialist with 12+ years experience supporting Clinical Operations Management in the areas of receiving and processing essential paper and electronic documents. Knowledge of GCP, ICH and SOP writing. Committed to excellence and accountability for providing accurate, efficient, and quality customer service in the best interests of the company and the safety of its patients. Offer a high degree of expertise in:
• Streamlined workflow by developing a new tracking system and authored desktop operating procedures for the Document Processing Center (DPC) at Celgene that eliminated the need to create multiple spreadsheets for each user and allowed multiple users at once - over local and wide area network.
• Less than 10% of DPC filing errors identified in annual TMF Quality Review.
• Key member of a team that corrected procedural inefficiencies and improved communications within department. Relations with study managers, coordinators and other clinical operations groups also improved significantly.
• Transferred knowledge to Abraxis colleagues/management in North Carolina on the DPC RRAD System and maintained coordination with IT regarding database replication issues (over wide area network) that were quickly resolved.
• Error rate on QC of transmittal packages <10% (tracked in metrics).

PROFESSIONAL EXPERIENCE:

Confidential

Senior Document Archiving Specialist

Responsibilities:

• Ensure the accuracy and completeness of the CRF/DCF transmittal packages received in the DPC by comparing the documents received to the transmittal form. Any discrepancies will need to be resolved before signing and documenting the date for process, image, and file the documents.
• Proper processing of redacted and non-redacted documents.
• Primary lead for off-site storage, collaborated with document sources / Facilities / Mailroom / Shipping / Security / IT and Iron Mountain contacts to prepare documents for storage in a centralized location as permitted by local regulations.
• Scan essential documents for upload to be bookmarked and hyper linked to online repository, Livelink for Clinical (LL4C).
• Basic use and navigation of electronic submission (eSub Livelink) after it has been approved for IND track for location and auditing purposes.
• Responsible for receiving of validation documents, assigning an identifier for each validation project, and finally, scanning and storing while maintaining a master list of all validation documents stored in the DPC.
• Receive Safety Letters from Clinical Operations for upload to LL4C and file in appropriate compound binders located in the DPC file room.
• Responsible for storage and tracking of Investigator Brochure (IBs) of versions as well as team members requesting IBs and quantity provided.
• Developed and maintained in-house tracking software, Records Retention Access Database (RRAD) for studies slated for archiving and filing, trained new users and kept daily back up to prevent file corruption.
• Key member of a process improvement team that corrected procedural inefficiencies, streamlined daily tasks and improved communications within department. Relations with study managers, coordinators and other clinical operations groups also improved significantly.
• Set up of Label/Folder creation according to the current and approve structure in the TMF Index Evaluated existing processes and recommended changes that increased efficiency and accuracy.
• Started development of the Clinical QA/QC Investigator and Vendor database for tracking purposes.
• Monitored storage vault capacity and notified management when vault meets 75% capacity.
• Filing all documents in the TMF or DPC Scanning Solution within five days of receipt of transmittal package in the DPC or upon resolution of transmittal form issues.
• Scanned and filed closed studies for the Document Archiving Specialists.
• Tracking of Trial Master File documents in preparation for archiving.
• Began development of the RRAD System for tracking archived studies.
• Provided support and assistance to the Document Specialists/Management as needed to support overall operations.

Confidential

Records Management Associate

Responsibilities:

• Scanned, indexed, and uploaded country-sponsored documents using Electronic Data Capture (EDC) for ELARA, a Pfizer in-house library for regulatory and subject documents.
• Supported department database and record retrieval process by verifying accuracy of information entered.
• Maintained assigned drug studies by preparing documents during archiving and retrieval of information. Handled time-sensitive FDA and Attorney General Queries by efficiently managing available resources with limited manpower to effectively resolve any types of requests on a timely basis.

Confidential

Clinical Data Coordinator

Responsibilities:

• Received, logged, and audited CRFs for quality content and format. Managed ID logs and reviewed CRFs from multiple study sites. Submitted incomplete data to Clinical Research Associates (CRA) for clarification. Coded completed CRF’s for data entry and verification. (All Phases).
• Reviewed and supported data cleanup activities with CRAs and Quality Assurance teams during quarterly audits for quality and integrity of data.
• Assisted the Clinical Research Scientist with X-ray verification, labeling, and filing. X-ray submission forms attached to X-ray films were entered into system for follow-up records, annotations and X-ray reviews.
• Provided a high level of support to Clinical Research Associates. Monthly reports were verified with the master patient list to note discrepancies. Radiographs were prepared for annotation and review by an independent agency as part of device evaluation.