Sherry Winckler

**** **** ** *** ***** Blvd South, East Stroudsburg, PA 18302

570-***-**** acdo3m@r.postjobfree.com

Experience

****- *******-******* *********** ******, NJ

(Contract)

Document Management Specialist, Document Processing Center

(DPC)

. Process and maintain electronic and paper clinical trial

documentation.

. Support project teams initiatives with filing, scanning, and

archiving.

. Identify and resolve documentation discrepancies with

various departments.

. Review, reconcile and process transmittal form packages.

. Perform quality control (QC) review of internal trial master

file (TMF) files.

. Perform all functions related to the DPC Scanning

Solution/electronic TMF including scanning,

image QC, indexing and index QC.

. Act as the central contact for clinical teams and vendors

for designated project communications, correspondence and

associated documentation.

. Provide resolutions to clinical teams with document

transmittal discrepancies.

. Create labels, folders, binders and prepare work area for

customers.

. Maintain the integrity of the DPC and the file room (room

access, closure, shelf organization, etc.)

. Maintain and track common area files (safety letters, IBs,

etc.)

. Create Trial Master File tracking system for (TMF) documents

in preparation for archiving.

. Orchestrate & verify 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.

. Maintain off site archiving facility documentation. Perform

data entry and data verification.

. Notify off site archiving facility of departmental pickup

and delivery status.

. Liaison with off-site archiving facility personnel to

resolve any issues during the archival process.

. Other duties as required.

2011- 2012 Clinforce-Merck Springfield, NJ (Contract)

Document Regulatory Associate

. 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.

1999-2009 Schering-Plough Pharmaceutical Company Springfield, NJ

Clinical Documentation Specialists

. 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 Certifications, Laboratory

Certifications/ 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 inquires 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 training according to their needs/training levels

and provided training resources.

Document Control Clerk

. Reconciled and organized the filing of study documentation.

. Retrieved study documents for the purpose of auditing FDA

submissions.

. Performed electronic data capturing of study file documents.

. Scanned study file documents for errors prior to electronic

data capture.

. Sorted and distributed mail.

. Ordered office supplies.

Data Collection Specialist/Clinical

Data Management

. Entered and verified clinical data using Windows based

system.

. Reviewed CRFs for accuracy and inconsistencies.

. Ensured data had been processed in order to meet projected

timelines.

. Tested database for design and accuracy.

. Performed random sampling checks for database finalization.

. Ensured SOPs and specific data entry conventions were met.

. Worked with CDC via e-mail or phone to identify and resolve

data collection issues.

1991-1999

Insurance Overload Systems Oakland, NJ

Customer Service Representative, Claims Adjuster

. Processed medical and dental claims.

. Verified all major medical insurances, retirees, and

Medicaid and Medicare patients.

. Posted payments and retrieved overpayments on patient

accounts.

. Outstanding knowledge of all medical terminology, CPT, ICD,

and ICD 10 codes as well as Medicaid and Medicare.

. Supervised and trained new hires.

. Billed all major insurance companies, hospitals and third

party administrators.

Education

2010-2011 Northampton Community College, Tannersville, PA

Medical Billing and Coding, Specialized Diploma

1979-1980 Bergen Community College, Paramus, NJ

Business Administration

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