Summary
Overview
Work History
Education
Skills
Tools Used
Timeline
Renee Wunderley

Renee Wunderley

Gibsonia,PA

Summary

Experienced research professional in healthcare and clinical research with 8+ years of experience. Skilled in overseeing and managing clinical trials, coordinating projects, managing clinical sites, and implementing process improvement strategies. Proficient in reviewing and revising clinical trial and project documents, resolving adverse events, and serving as the point of contact for vendors, stakeholders, and sponsors.

Overview

8
8
years of professional experience

Work History

Associate Manager, Trial Operations

Global Coalition for Adaptive Research
12.2021 - 10.2023
  • Optimized clinical operations by creating effective CRO oversight strategies, ensuring critical processes were defined
  • Provided valuable insights on enhancing site management by thoroughly assessing visit reports, resulting in improved practices and compliance
  • Revise and update research plans to align with present-day global methodologies and procedures
  • Boosted site activation by redesigning procedures and monitoring execution effectiveness, resulting in 8 sites' activation in 30 days
  • Instituted creative solutions for efficient vendor invoice review and approval, ensuring timely delivery of approved invoices
  • Improved study start-up management by implementing streamlined document review process that ensured completeness and accuracy of all documents
  • Detected inaccuracies were communicated promptly to CRO for resolution
  • Led development of detailed technical presentations for initial meetings with pharmaceutical partners, resulting in enhanced understanding of trial processes and improved partnerships
  • Constructed instructional materials for clinical operations team on data privacy practices, processes, and new employee references.
  • Remedied issues and conflicts among workers using negotiation and active listening.
  • Set and enforced performance and service standards to keep consistent, high-quality environment devoted to customer satisfaction.
  • Supervised day-to-day operations to meet performance, quality, and service expectations.

Research Project Manager

University Of Pittsburgh
11.2020 - 12.2021
  • Elevated clinical site performance by conducting monthly site meetings with PIs and lead research coordinators, improving site concerns, and fostering strong relationships
  • Conducted frequent data entry reviews and touch bases and created tracking tools to ensure data completeness
  • Successfully managed protocol amendment reviews with trial sponsor and pharmaceutical collaborators, resulting in stronger partnerships and improved clinical trial operations
  • Introduced trial to perspective clinical sites to increase participation and manage growth.
  • Monitored project progress, identified risks, and took corrective action as needed.
  • Maintained open communication by presenting regular updates on project status to customers.
  • Used critical thinking to break down problems, evaluate solutions, and make decisions

Clinical Research Coordinator

University Of Pittsburgh Asthma Institute
08.2015 - 11.2020
  • As overseer of clinical trials, primary responsibilities involved participant recruitment, trial visits, and ensuring diverse pool of participants to guarantee accuracy and reliability of data
  • Successfully identified and recruited 120+ participants, resulting in improved data accuracy and accelerated trial timelines
  • Implemented process improvement strategies to streamline clinical trial procedures amid challenges posed by COVID-19
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

Education

Bachelor Of Arts -

La Roche College, Pittsburgh, PA
2004

Skills

  • Attention to Detail
  • Clinical Research
  • Critical Thinking
  • Adaptability and Flexibility
  • Organizational Skills
  • Process Improvement
  • Risk Analysis
  • Budgeting: Invoice Verification, Statement Of Work
  • GCP
  • Written Communication
  • Decision Making
  • Teamwork and Collaboration
  • Computer Skills
  • Project Management
  • Operations Management
  • Records Organization and Management

Tools Used

  • Adobe Acrobat
  • ESOCDAT database
  • Excel
  • G-mail
  • Google Drive
  • IMedidata
  • Microsoft Excel
  • Microsoft Office
  • Word
  • Microsoft Teams
  • Monday.com Software
  • MS Teams
  • Oracle database
  • Outlook
  • REDCap
  • Trello
  • Venngage

Timeline

Associate Manager, Trial Operations - Global Coalition for Adaptive Research
12.2021 - 10.2023
Research Project Manager - University Of Pittsburgh
11.2020 - 12.2021
Clinical Research Coordinator - University Of Pittsburgh Asthma Institute
08.2015 - 11.2020
La Roche College - Bachelor Of Arts,
Renee Wunderley