ERICA EVANS
Indianapolis,IN
Summary
Research Professional with expertise in regulatory coordination, clinical compliance, and FDA submissions within oncology trials. Achieved significant contributions to the approval of innovative medical products by streamlining submission procedures and fostering collaborative relationships with regulatory bodies. Focused on enhancing workflow efficiency and ensuring alignment with global compliance standards across diverse markets. Extensive experience as Program Manager with background in leading diverse teams to accomplish project objectives. Strengths include strategic planning, process improvement, and stakeholder management. Known for leveraging technical skills to improve organizational efficiency and drive project success. Previous work contribution includes streamlining processes for improved productivity and implementing innovative program strategies that increased overall performance.
Overview
12
12
years of post-secondary education
16
16
years of professional experience
Work History
Research Regulatory Coordinator
Community Health Network, Inc.
Indianapolis, IN
11.2022 - Current
- Oversaw regulatory portfolio for oncology and stem cell transplant trials, managing study startups and lifecycle reporting to ensure adherence to regulatory standards.
- Coordinated FDA submissions, including expanded access protocols, while maintaining regulatory compliance across approval processes.
- Established documented workflows for standard practices, reinforcing regulatory compliance across research activities.
- Transitioned 30 studies, streamlining thousands of documents to improve insights and efficiency within Florence system.
- Integrated Greenphire into trials through collaboration with teams, sponsors, and IRBs.
- Developed training materials to equip Regulatory staff with necessary knowledge and skills during Florence transition.
- Conducted Practice Council investigations and proposed user-approved solutions.
- Ensured compliance with federal and state regulations in healthcare operations.
- Reviewed documents for accuracy and completeness prior to submission.
- Communicated with stakeholders regarding regulatory requirements and updates.
- Maintained comprehensive documentation for audit readiness and inspections.
- Assisted in the development of internal policies related to regulatory affairs.
- Monitored changes in regulations impacting organizational practices and procedures.
- Collaborated with cross-functional teams to support regulatory strategies and initiatives.
- Collaborated with other departments to create effective protocols for submitting documentation.
- Researched industry trends and developments related to global regulations.
- Provided guidance on best practices for meeting specific regulatory requirements.
- Advised management on potential risks associated with non-compliance issues.
- Facilitated communication between internal teams regarding regulatory matters.
- Communicated with external stakeholders to provide timely updates on submission statuses and address regulatory concerns.
- Built relationships with pharmaceutical companies to enhance collaboration on regulatory initiatives.
- Provided strategic regulatory input to internal and external stakeholders in compliance with FDA regulations.
Senior Program Manager
Roudebush VA Medical Center
Indianapolis, IN
12.2018 - 11.2022
- Orchestrated move of 80+ individuals into a new location, executing a seamless transition with minimal operational disruption.
- Directed grant submission team, optimizing workflows to increase funding success rates.
- Implemented research financial management system across multiple sites, enhancing financial oversight and reporting.
- Directed grant submission team, streamlining workflows to improve funding success rates.
- Coached staff in research project management to ensure efficient project execution.
- Coached staff in research project management, enhancing project execution across teams.
- Designed, developed, and maintained databases for compliance tracking, enhancing data-driven decision-making.
- Developed and managed program plans, schedules, budgets, and performance metrics.
- Managed change requests related to scope changes or requested modifications during the course of a project.
- Managed change requests related to scope changes, ensuring alignment with project goals.
- Conducted investigations with the Equal Employment Opportunity Office to resolve complaints.
Project Manager
Roudebush VA Medical Center
Indianapolis, Indiana
11.2013 - 12.2018
- Directed 10 simultaneous clinical research projects, ensuring on-time completion.
- Coordinated clinical research projects from proposal development to results reporting, aligning outcomes with project goals.
- Led project planning and execution for research initiatives.
- Coordinated cross-functional teams to ensure timely completion of research projects.
- Administered research budget, completing projects within established constraints.
- Tracked clinical research progress against milestones, facilitating informed decision-making for stakeholders.
- Maintained regulatory adherence across clinical research programs and study processes.
- Analyzed clinical data using advanced techniques to inform future research planning.
- Shared study information with stakeholders to improve transparency and alignment.
- Collaborated with senior management on strategic planning initiatives to guide project direction and execution.
Research Assistant/Program Assistant
Roudebush VA Medical Center
Indianapolis, Indiana
08.2010 - 11.2013
- Conducted participant selection for clinical trials based on specific eligibility criteria. through recruitment and eligibility assessments.
- Administered outcome assessments for clinical trial participants to support reliable data.
- Streamlined administrative processes to better support scientists at an international research center.
- Coordinated with team members to schedule and conduct participant interviews.
- Managed data collection and entry using electronic health record systems.
- Coordinated scheduling and conducting of participant interviews to ensure timely engagement in research studies.
- Improved administrative processes to enhance support for scientists in research operations. for scientists at an international research center.
- Maintained organized records of research activities and participant information to support data integrity and accessibility.
- Prepared reports, presentations, and articles using Microsoft Word and PowerPoint.
Education
Master of Library And Information Science - Library & Information Science
Indiana University
Indianapolis, Indiana 08.2023 - 05.2026
Clinical Professional -
Association of Clinical Research Professionals
08.2024 - 10.2024
Bachelor of Arts - Sociology
Indiana University Purdue University Indianapolis
Indianapolis, IN 08.2008 - 12.2017
Skills
- Clinical Trial Management
- Clinical Trial Startup
- Regulatory Management
- FDA Submissions and Interactions
- Regulatory Documentation
- Clinical Data Management
- Data Analysis
- Research methodology
- Research experience
- Research Budgets
- Project Management
- Program Management
- Lifecycle Reporting
- Fact Finding
- Personnel Management
- Grant Management
- eISF
- CTMS
- IRB
- Team leadership
- Effective communication
- Document management
- Regulatory planning
Affiliations
- Community Health Network Clinical Research Institute Practice Council, Co-Chair Indianapolis Public Library, Computer Support Volunteer
- ACLU of Indiana, Legal Intake Volunteer Big Brothers Big Sisters of Central Indiana, Big
- RLR VAMC LGBT Committee, Co-Chair Combined Federal Campaign Planning, Member
- HSR&D Data Security Committee, Member RLR VAMC Diversity Advisory Committee, Member
- RLR VAMC LGBT Veteran Workgroup, Member
- RLR VAMC Memorial Service Providers, Member
- RLR VAMC Sexual Harassment Prevention Training Initiative, Trainer
- Keep Indianapolis Beautiful Inc., Project Volunteer
Timeline
Clinical Professional -
Association of Clinical Research Professionals
08.2024 - 10.2024
Master of Library And Information Science - Library & Information Science
Indiana University
08.2023 - 05.2026
Research Regulatory Coordinator
Community Health Network, Inc.
11.2022 - Current
Senior Program Manager
Roudebush VA Medical Center
12.2018 - 11.2022
Project Manager
Roudebush VA Medical Center
11.2013 - 12.2018
Research Assistant/Program Assistant
Roudebush VA Medical Center
08.2010 - 11.2013
Bachelor of Arts - Sociology
Indiana University Purdue University Indianapolis
08.2008 - 12.2017