CHELSEY ROGERS
COLUMBIA,TN
Summary
To obtain a position in a Health Care Facility, that will allow me to grow professionally, while being able to utilize my strong organizational, exceptional people skills and to provide quality health care.
Experienced with regulatory compliance, coordination, and documentation. Utilizes effective communication and organizational skills to ensure adherence to regulatory standards. Track record of successfully managing regulatory processes and collaborating with cross-functional teams to achieve compliance objectives.
Detail-oriented individual with exceptional communication and project management skills. Proven ability to handle multiple tasks effectively and efficiently in fast-paced environments.
Overview
12
12
years of professional experience
Work History
Research Regulatory Coordinator
OneOncology
Nashville, TN
03.2025 - Current
- Processes regulatory document signature request through electronic signature platform
- Tracks documents pending site regulatory signatures
- Provides site level regulatory support to the Clinical Operations’ sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
- Establishes and maintains a document management system for regulatory paper and electronic files
- Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
- Maintains updated physician credentials for network participants and other critical documentation ensuring compliance
- Triages site requests for regulatory support and identifies correct pathway for issue resolution
- Submittals to Investigational Review Board for assigned studies
- Attends network meetings, conference calls and monthly staff meetings as appropriate
- Participates in educational activities and programs
- Performs related work as required
- All other duties as assigned
Research Regulatory Coordinator
Tennessee Oncology
Nashville, TN
12.2023 - 03.2025
- Processes regulatory document signature request through electronic signature platform
- Tracks documents pending site regulatory signatures
- Provides site level regulatory support to the Clinical Operations’ sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
- Establishes and maintains a document management system for regulatory paper and electronic files
- Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
- Maintains updated physician credentials for network participants and other critical documentation ensuring compliance
- Triages site requests for regulatory support and identify correct pathway for issue resolution
- Submittals to Investigational Review Board for assigned studies
- Attends network meetings, conference calls and monthly staff meetings as appropriate
- Participates in educational activities and programs
- Performs related work as required
- All other duties as assigned
Regulatory Coordinator
Sarah Cannon Research Institute
Nashville, TN
10.2019 - 12.2023
- Processes regulatory document signature request through electronic signature platform
- Tracks documents pending site regulatory signatures
- Provides site level regulatory support to the Clinical Operations’ sites and internal department managers in relation to the status of start-up and ongoing regulatory maintenance
- Establishes and maintains a document management system for regulatory paper and electronic files
- Maintains FDA and GCP required regulatory documentation for individual sites, studies, sponsors and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
- Maintains updated physician credentials for network participants and other critical documentation ensuring compliance
- Triages site requests for regulatory support and identifies correct pathway for issue resolution
- Attends network meetings, conference calls and monthly staff meetings as appropriate
- Participates in educational activities and programs
- Performs related work as required
- All other duties as assigned
Document Control Specialist
Sarah Cannon Research Institute
Nashville, TN
07.2018 - 10.2019
- Manages the electronic filing of IND Safety Reports and assist in processing Safety Notifications per the Sarah Cannon Policy and related Good Practicing Guidelines.
- Oversees the process of obtaining Physician signatures required.
- Established and maintains a document management system for regulatory paper and electronic files, Archives study specific regulatory documentation and correspondence.
- Attend regulatory staff meetings as appropriate.
- Assists any internal and external audit team with regularly related issues.
- Interact with on-site monitors and respond to queries from pharmaceutical company and study monitors.
- Maintains strictest confidentiality.
- Provides administrative support to the RAS as necessary.
Revenue Cycle Management-Billing Specialist
Premise Health
Brentwood, TN
09.2014 - 07.2018
- Generate and process daily deposits for multiple sites.
- Accountable for balancing electronical daily deposits for over 40 accounts.
- Answer customer account and billing questions.
- Accurately enter data into application systems.
- Answer questions from patients, clinical staff, and insurance companies.
- Identify and resolve patient billing complaints.
- Review accounts for possible assignment and make corrections.
- Process payments and apply to the patients account.
- Sort and distribute department mail.
- Various administrative functions for department, as needed.
- Maintain strictest confidentiality.
Education
Associates of Health Science -
Columbia State Community College
Columbia, TN08.2026
Pharmacy Technician - undefined
Columbia State Community College
Columbia, TN05.2014
Skills
Relationship Building, Problem Solving, Writing/Presentation, Communication, Organized, Detail Oriented, Customer Service, Training, Team Player, and Strong Computer Skills
Regulatory submissions
Document control
Multitasking Abilities
Excellent communication
Critical thinking
Organizational skills
Team collaboration
Timeline
Research Regulatory Coordinator
OneOncology
03.2025 - Current
Research Regulatory Coordinator
Tennessee Oncology
12.2023 - 03.2025
Regulatory Coordinator
Sarah Cannon Research Institute
10.2019 - 12.2023
Document Control Specialist
Sarah Cannon Research Institute
07.2018 - 10.2019
Revenue Cycle Management-Billing Specialist
Premise Health
09.2014 - 07.2018
Pharmacy Technician - undefined
Columbia State Community College
Associates of Health Science -
Columbia State Community College