SUMMARY:

• Find a challenging career in which I could implement my knowledge for advancement within the medical administrative field.

WORK EXPERIENCE:

Confidential

Scanning Operator

Responsibilities:

• Perform Quality Check on paper documents retrieved as per work process and instruction guide and on the electronic copy to ensure conformity with paper document.
• Maintain the finding in tracker.
• Coordinate with offsite team and provide details of documents mentioned in tracker for importing them in CREDI.
• File documents back in the relevant indexing structure/archive location.
• Saving documents by providing naming conventions as per regulatory guidelines.

Confidential

Documentation Quality Assurance Assistant

Responsibilities:

• Collected, organized, identify and filed all quality records as follows: processed validation protocols, reports and raw materials of analysis, finished product . Executed batch records and deviation reports.
• Maintained archive system for off - site storage, so documents and batch records can be retrieved when requested.
• Maintained controlled active documents file per (SOP), master batch records, change control forms, quality agreements and quality audits.
• Preformed document packages as required by Regulatory department. Printed Batch records received from manufacturing tollers and Update the Annual Product Report.
• Organized and identified Standard Test Producers, Stability Reports, Quality Control and Validation Reports.
• Responsible for ensuring appropriate controls for the identifications, storage, protection, retrieval, retention time and disposition of quality records.
• Collected invoices, bill of lading, purchase orders and Fed ex invoices for organization and filing.
• Sorted, filed and retrieved documents from the filing area; maintained and implemented a system of retrieving files that have been checked out.

Confidential

Clinical Document Associate

Responsibilities:

• Performed manual data entry for CTMS, TMF’s, CRF’s, lists, records, verification and other data.
• Performed system administration activities required to activate, initiate, closeout study sites or studies in clinical trials and manage the input of data into specific applications.
• Monitors and tracks appropriate documentation to meet the contracted and SR Timelines.
• Maintains weekly document processing metric, errors and returns.
• Ensures consistent receipt analysis, classifications, registration and disposition, filing and retrieval of hardcopies and electronic clinical trial essential document and other clinical trial related document to allow for their consistent tracking, inspection and security.
• Verifying content codes and any other data to be input into the database (Documentum).
• Contacted monitors for any problems or questions about batch records.
• Knowledge of commonly-used concepts, practices and procedures within a particular field.
• Making corrections or contact the preparers of the source documents to resolve an issues with the documents.

Confidential

Office Assistant

Responsibilities:

• Responsible for helping out in the office; filing paper work, sending out notices, making copies, going to the post office and entering customers information into the database.
• Customer service - answering phones.
• File and maintain clinical research & Development of study documents.
• Receive and process records for storage, including receipt verification and quality checking.
• Scan documents and conduct document validation during scanning process.
• Ensure all records/documents are processed according to SOPs and ready for retrievable.
• Perform other duties as assigned.
• Entering data to be input into the database (Oracle).

Confidential

Documentation Control Clerk

Responsibilities:

• Responsible for the acceptance of clinical documents into the department, including receipt verification and quality checking headers on document and transmittal forms.
• Assisted with the Administrative duties as needed for distribution of documents to the proper therapy area.
• Reconciled scanned documents for completeness and accuracy.
• Retrieved clinical documents for the purpose of Quality Assurance, Auditing, and FDA submissions. Proposed corrections to clinical documents based on SOP.
• Maintained MS Access databases to monitor documents requested and retrieved for multiple therapeutic areas.
• Scanned documents into a system for electronic access and viewing using a Kodak DS document capture system.
• Ability to resolve scanning issues using Re-scan software according to individual document errors.
• Performed quality check of filmed Clinical documentation to ensure accuracy of developed 6mm microfilm reels.
• Assisted in new staff adherence to SOP guidelines surrounding trial master files documentation, reviewing microfilm and proper document/microfilm reconciliation.
• Filed Clinical documents according to internal SOP’s.
• Communicated with internal personnel for resolve filing/scanning issues.
• Performed Quality checks on scanned documents if any issues were reported.
• Handled clinical documentation request for external monitors.
• Assisted with other projects as assigned.

Confidential

Senior Data Document Processing Specialist

Responsibilities:

• Responsibilities included the preparation of clinical information documents for distribution, copying, filing and shipping for multiple pharmaceutical companies, scanned, indexed and entered data into clinical trial databases (Oracle) for CDM liaison between clinical and data groups regarding data accuracy issues.
• Performed Quality Assurance checks for clinical trail databases and final reports.
• Responsible for all data entry, medical coding, keying and verification of clinical data, filing, faxing and typing. Handled receiving and shipping invoices, answering phones, copies and other office duties that were required during different assignments.