Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Paula Tirrell

Ortley Beach ,NJ

Summary

Detail-oriented, data associate well-versed in multiple computer software programs with decades of experience in office administration and data management.

Excellent problem-solving abilities with an ability to learn type of nature. Ready to bring 20+ years of related experience to a challenging new role.

Professional with numerous years of experience optimizing productivity, efficiency and service quality across various environments.

Highly dependable, ethical and reliable support and works effectively with cross-functional teams in ensuring operational and service excellence.

Overview

34
34
years of professional experience
1
1
Certification

Work History

Manufacturing Quality Coordinator

Renaissance Pharmaceuticals
Lakewood, NJ
07.2023 - 08.2024
  • Entered data, generated reports, and produced tracking documents.
  • Improved team productivity with regular communication and progress updates, fostering a collaborative work environment.
  • Enhanced operational workflows by maintaining well-organized documentation systems and updating records accurately as needed.
  • Gathered and organized materials to support operations.

LIMS Administrator

Renaissance Pharmaceuticals
Lakewood, NJ
09.2022 - 07.2023
  • Entered, reviewed and maintained database records in LIMS database. Assisting with data transfer and review of data information for compliance.

Office Manager

Tirrell Landscaping & Lawn Maintenance
11.2016 - 06.2021
  • Quickbooks
  • Performed billing, collection, payroll, customer support and all pertinent information coordination.
  • Streamlined office operations by computerizing activities, managing customer communications, scheduling payments and tracking records and documents.
  • Prepared vendor invoices and processed incoming payments.
  • Interacted with customers professionally by phone, email or in-person to provide information and directed to desired staff members.
  • Coordinated and maintained impressive office organization to keep facilities efficient, organized and professional.
  • Verified salaried and hourly employee time cards to prepare accurate bi-weekly payroll.
  • Maintained computer and physical filing systems.

Collections Manager

Bureau Of Accounts Control
03.2011 - 05.2016
  • Set up and updated customer accounts and CRM with interactions, payments and personal information.
  • Contacted customers to collect outstanding payments via one-time or negotiated installment methods.
  • Followed prescribed scripts and maintained friendly but firm attitude with full knowledge of contractual requirements and legal remedies.
  • Supervised staff of collectors, monitoring phone calls and letters.
  • Processed payments and applied to customer balances.

Clinical Data Manager

Beardsworth Consulting Group
01.2003 - 12.2010
  • Planned and implemented in-depth studies.
  • Assisted with database upgrades and migrations by performing user acceptance testing.
  • Collected, reviewed and analyzed data from diverse departments..
  • Worked with programming to coordinate Study Data Tabulation Model maps.
  • Built and deployed plans, reports, validation procedures and entry processes for data management needs.
  • Designed, deployed, validated and finalized database systems for operations.
  • Upheld critical security standards when managing user access actions such as setting up and removing accounts.
  • Led team in delivery of projects, resulting in database closures.
  • Resolved problems, improved operations and provided exceptional client support.
  • Developed team communications and information for meetings.

Lead Clinical Research Associate

Kendle
08.1997 - 12.1999
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.

Senior Clinical Research Associate

Schiff & Company
01.1991 - 08.1997
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Generated and upload assay data and communicated results and reports to multi-disciplinary project teams to influence progression in discovery and development.
  • Communicated project status to management verbally and through technical documentation and presentations.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
  • Collected data and followed research protocols, operations manuals and case report form requirements.

Education

High School -

Lacordaire Academy
Upper Montclair, NJ
06.1989

Skills

  • Database Administration
  • Documentation and Control
  • Policy and Procedure
  • Account Reconciliation
  • Clerical Support
  • Project Management
  • Bookkeeping
  • Credit and Collections
  • Office Management
  • Office Administration
  • Program Management
  • Administrative Support

Certification

  • GCP Certified for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) Course (Curriculum Groups and Course Learner Group) CITI Program Course - July 28, 2022
  • 21 CFR Part 11 Electronic Signatures and Documentation certification.

Timeline

Manufacturing Quality Coordinator

Renaissance Pharmaceuticals
07.2023 - 08.2024

LIMS Administrator

Renaissance Pharmaceuticals
09.2022 - 07.2023

Office Manager

Tirrell Landscaping & Lawn Maintenance
11.2016 - 06.2021

Collections Manager

Bureau Of Accounts Control
03.2011 - 05.2016

Clinical Data Manager

Beardsworth Consulting Group
01.2003 - 12.2010

Lead Clinical Research Associate

Kendle
08.1997 - 12.1999

Senior Clinical Research Associate

Schiff & Company
01.1991 - 08.1997

High School -

Lacordaire Academy
Paula Tirrell