Highly-motivated employee with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills. Hardworking employee with customer service, multitasking, and time management abilities. Devoted to giving every customer a positive and memorable experience.
Overview
18
18
years of professional experience
Work History
Records/Document Services Associate/Reception
MCS GROUP, Inc – Greenbaum, Rowe, Smith & Davis
03.2025 - Current
Greeting and welcoming clients, visitors and guests with professional and friendly demeanor
Answering inquiries: providing general information about the company
Receiving, sorting, and distributing incoming mail and packages.
Efficiently answering, screening, and forwarding incoming calls to appropriate individuals or departments.
Assisting with conference room bookings
Performing basic data entry tasks, updating contact lists, and maintaining records
Filing organizing and maintaining physical and digital records
Providing general administrative and clerical support as needed
Photocopying and scanning
Managing meeting rooms
Handling minor office equipment issues (e.g printer jams, phone problems) or escalating them to appropriate personnel.
Substitute Paraprofessional
ESS
12.2024 - 03.2025
Provide instructional support and reinforcement for individual students and small groups, ensuring alignment with classroom objectives
Assist in classroom management and general supervision, contributing to a productive and safe learning environment.
Support students with special needs by adhering to their IEPs/504 Plans, addressing their physical, personal, academic, and emotional requirements
eTrial Master File Analyst
Bristol Myers Squibb, Summit NJ
Summit, NJ
01.2019 - 12.2023
Recognizes, confirms quality, and uploads large volume of TMF documents, maintaining high quality standards and completes process within required timelines
Monitors the adherence to ICH/GCP Guidelines, regulatory requirements, ALCOA+ Principles and BMS policies as it relates to the completeness and accuracy of the TMF at the document level.
Exhibits knowledge of critical and essential documents to be able to perform Quality Validation checks on documents that have had completed quality review.
Subject Matter Expert knowledge of clinical trial documentation, TMF Reference Model, navigation of the eTMF system, clinical trial activities and related terminology
Manages complex tasks within a Trial Master File, including Template and Report creation.
Participates in execution of UAT scripts for eTMF system releases
Ability to make sound business decisions based on evidence (guidance documents and Manual of Operations) and experience regarding the outcome of the work that is performed that involves critical or complex documents.
Participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection
Demonstrates ability to make decisions, deliver on commitments, share knowledge, acknowledge other achievements, and collaborate with peers to meet objectives or timelines in a rapidly changing environment.
Coordinator, Essentials Document Management (EDM)
Celgene, Summit NJ
Summit, NJ
11.2017 - 01.2019
Receive, track and quality check TMF transmittal packages
Follow-up with study team and functional area reps to resolve any issues
Scan paper TMF transmittal packages
Create folders for paper studies and file paper documents received
Quality check electronic documents submitted to the eTMF system
Return documents to submitters if quality is no adequate
Follow-up on rejected documents to ensure timely resolution of issues
Monitor DPC support mailbox and respond to requests for DPC/eTMF support (e.g document deletions, moves and renames)
Retrieve folders from file room for document review and prepare work area for study teams
Process casebooks and perform casebook quality checks, as required.
Track and quality check data in records management.
Clinical Document Steward
R&D Partners on assignment with Celgene, Summit NJ
Summit, NJ
02.2017 - 11.2017
Collect, review and scan paper documents
Review electronic documents submitted
Return documents to submitters if quality is not adequate
Follow-up on rejected documents to ensure timely resolution of issues
Monitor mailbox
Create folders for paper studies and file paper documents received
Fulfill requests for copies of TMF documents that are offsite to requestors
TMF Reviewer
Apex Systems, Inc on assignment with Daiichi Sankyo, Edison NJ
Edison, NJ
09.2016 - 02.2017
Executes the electronic QC of documents uploaded to the Daiichi Sankyo First Doc System (DSfD) to ensure filing quality and consistency.
Uploads and indexes documents received in paper into DSfD eTMF system.
Receive, QC, and transfer electronic content received from CRO’s and Vendor’s into DSfD eTMF.
Conducts reconciliation and filing of wet ink documents received from internal and external study team members.
Prepares paper files and electronic media for off-site archival.
Provides assistance to internal and external study team members in document uploading and TMF guidance.
File Support Specialist
R&D Partners on assignment with Celgene, Summit NJ
Summit, NJ
12.2013 - 09.2016
Receives, stamps, and tracks all document transmittal forms
Review, reconciliation, and processing of transmittal form packages – includes issue resolution with submitter of documents/transmittal
Files paper and electronic documentation in the DPC (Data Process Center)
Creates labels, folders, binders and prepares work area for customers
Prepare, scan, QC and file clinical documents
Maintains the integrity of the DPC and the file room (room access, closure, shelf organization, etc)
Maintains and tracks common area files (safety letters, IBs, etc)
Tracking of Trial Master File (TMF) documents in preparation for archiving
Orchestrates offsite storage
Assist with training of new staff members
Senior Clinical Project Administrator
COVANCE, Princeton, NJ
Princeton, NJ
06.2009 - 06.2013
Provide clerical support for clinical projects according to Covance Standard Operating Procedures(SOPs)
Maintain administrative systems (tracking and other) for clinical projects according to Covance SOPs
Assume coordinating role for the project team concerning administrative matters
Train and mentor Clinical Project Administrators
Provide clerical support to the project team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)
Set up and maintain clinical investigator files and documentation
Prepare study-related documents and other materials for delivery to archives, at appropriate intervals
Track and file Essential Documents
Prepare monitoring visit documentation for Clinical Research Assistants and above, as requested by supervisor
Data entry and maintenance of selected study tracking data and team calendars
Assist in coordinating vendors and project plans
Assist/prepare for client or internal audits
Provide telephone coverage and related support duties for clinical hotline
Coordinate Sr. Director’s calendar and travel arrangements
Clinical Data Processor I
COVANCE, Princeton, NJ
Princeton, NJ
05.2007 - 06.2009
Trained new data acquisition staff (temporary and permanent)
Prepared Data Entry and Data Imaging Conventions
Performed scanning, imaging and indexing of data/documents
Received and logged-in controlled documents
Assisted with the preparation of controlled documents prior to data processing/imaging as requested
Coded controlled documents prior to entry/imaging according to established conventions
Entered clinical data into the appropriate database via data screens/imaging media (first pass entry)
Verified clinical data entered via data screens/imaging media into the database (second pass entry)
Resolved unverified records or discrepancies to ensure data was available for data review activities
Created and maintained study files
Generated queries for simple discrepancies during the data entry process as required by study specific conventions
Edited clinical data on the database
Assisted with printing of query resolution documents as requested
Archived study DCT, documentation and controlled documents
Interacted with Data Management on Data problems
Education
High School - Business Liberal Arts
Piscataway High School
Piscataway, NJ
01.1998
Skills
Data entry
File organization
Customer service
Attention to detail
Time management
Administrative support
Office equipment troubleshooting
Timeline
Records/Document Services Associate/Reception
MCS GROUP, Inc – Greenbaum, Rowe, Smith & Davis
03.2025 - Current
Substitute Paraprofessional
ESS
12.2024 - 03.2025
eTrial Master File Analyst
Bristol Myers Squibb, Summit NJ
01.2019 - 12.2023
Coordinator, Essentials Document Management (EDM)
Celgene, Summit NJ
11.2017 - 01.2019
Clinical Document Steward
R&D Partners on assignment with Celgene, Summit NJ
02.2017 - 11.2017
TMF Reviewer
Apex Systems, Inc on assignment with Daiichi Sankyo, Edison NJ
09.2016 - 02.2017
File Support Specialist
R&D Partners on assignment with Celgene, Summit NJ