Clinical Data Management/Research

Renada A. Woodford

** ***** ******, ***. *

East Stroudsburg, Pa 18301

570-***-**** (Home)

570-***-**** (mobile)

PROFILE

• A highly motivated and well organized individual with experience in reviewing, processing and managing Clinical Trial Master Files and FDA submission documents. Knowledgeable on ICH/GCP/GMP/GLP guidelines.

• Detail oriented with the ability to balance competing priorities and administer a broad range of responsibilities effectively.

• Excellent verbal and written communication skills with strict adherence to detail and quality.

PROFESSIONAL EXPERIENCE

Sanofi Pasteur (Yoh) -Swiftwater, PA 6/11-Present

Data Audit Specialist

• Responsible for the comparison of raw laboratory data results to their reported values for all clinical studies.

• Identify and resolve discrepancies according to SOP/SWI.

• Approve and signoff on error free finalized Audit Reports.

• Preparation of error free data reports for export to Clinical Data Management

• Conducts audits in accordance with company standard operating procedures and quality policies.

• Appropriately escalate and resolve any compliance issues.

• Draft and issue periodic reports to site management as requested.

CRO-Quintiles Transnational (Aerotek) – Parsippany, NJ 11/10-6/11

Senior Clinical Trials Assistant

• Responsible for assisting the Clinical Team Lead and Clinical Research Associates with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.

• Collaborate with CTL on the preparation, handling, distribution, filing, and archiving of clinical documentation reports according to the scope of work and standard operating procedures.

• Periodic review of study files for accuracy and completeness.

• Responsible for the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.

• Responsible for the tracking and management of Case Report Forms (CRFs), queries and clinical data flow

• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation via Share Point and Share Web.

• Perform assigned administrative tasks to support team members with clinical trial execution.

• Assist in mentoring, training and orienting new staff.

• Accompany CRAs on site visits to assist with clinical monitoring.

Schering Plough Research Institute- Springfield, NJ 10/06-12/09

Clinical Documentation Specialist

• Responsible for identification of Trial Maser Files (TMF’s) submitted to the central file; classified and attributed appropriately using a sophisticated ORACLE-based system (Clinical Documentation Information Tracking System – Documentum).

• Reviewed TMF’s for accuracy, completeness, 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 arrange 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 and 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 as prompt as possible.

• Distinguished and evaluated potential document errors and actively used proper guidelines to correct inaccuracies for document acceptance.

• Train and closely mentor 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.

Prudential Financial- Livingston, NJ 11/99-8/01

Medical Underwriter

• Reviewed applications and evaluated medical records in efforts to apply established underwriting guidelines to accept or deny applications for life, long term and short term disability insurance through the medical underwriting system.

Silikker Laboratories- Garfield, NJ Summer 1999

Microbiology Laboratory Technician

• Preparation of various food products for the analysis of E.coli, Salmonella and Listeria.

National Starch & Chemical- Bridgewater, NJ Summer 1999

Chemistry Laboratory Technician

• Preparation of adhesives for the determination adhesive strength at various temperatures.

OTHER EXPERIENCE

Karate for Youth Child Care Services - Maplewood, N.J, Center Manager- 12/05 – 3/06

Hollywood Kiddie Quarters - Union, N.J - Abbott Pre-School Teacher- 8/01 - 7/04

8/99-11/99 St. Michael’s Medical Center - Newark, N.J - Patient Registrar- 8/99 – 11/99

EDUCATION

Rutgers University - Newark, New Jersey

BA Biology, Pre-Medicine

CERTIFICATIONS

Certified Phlebotomy Technician

COMPUTER SKILLS

Proficient in MS Office Software, Adobe Acrobat, Medical Terminology and CDITS (Clinical Documentation Tracking System-Documentum), Sharepoint, Shareweb, LIMS (Line Information Management System).

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