Amy Boegel
Clarksville
Summary
Accomplished healthcare operations leader with 10+ years of progressive experience at Vanderbilt University Medical Center. Expert in strategic planning, project management, and cross-functional team leadership. Proven track record of optimizing operational processes and driving measurable improvements in productivity and efficiency through data-driven decision-making and effective stakeholder communication.
Overview
15
15
years of professional experience
Work History
Regulatory Manager
Vanderbilt Ingram Cancer Center
Nashville
02.2025 - Current
- Manage and lead the VICC Clinical Trials Office Regulatory Team, ensuring efficient operations and strategic oversight of regulatory compliance activities.
- Provide expert leadership in developing, preparing, and implementing regulatory strategies to support cancer clinical trials.
- Coordinate regulatory workflows to expedite protocol approvals and ensure timely study activation.
- Oversees regulatory framework, determines pathways and options, and interacts with sponsors, agencies, and other academic institutions.
- Ensure regulatory compliance across VICC’s extensive and complex clinical trial portfolio.
- Oversee and audit the creation, development, and revision of protocols, informed consent documents, and clinical research documentation.
- Approve protocol and document submissions to internal and external regulatory bodies (e.g., Institutional Review Board), ensuring trial consistency with approved proposals.
- Direct study activations and regulatory activities for the VICC Clinical Trials Office.
- Oversee regulatory data management activities and maintain electronic regulatory files and binders tracking study milestone progress (e.g., OnCore clinical trial management system, IRB databases, internal/external spreadsheets).
- Review documentation supporting regulatory filings and prepare annual progress reports for IRB renewal of ongoing studies.
- Prioritize and manage workloads for the VICC Clinical Trials Office Regulatory Team.
- Lead comprehensive compliance reviews, including close-out and regulatory reporting.
- Organize team meetings and actively participate in committees, task forces, and ad hoc groups.
- Lead clinical training and staff development initiatives while maintaining and enhancing quality assurance programs.
- Vanderbilt University Medical Center – Nashville, Tennessee
Clinical Trial Research Manager
Vanderbilt University Medical Center
Nashville
02.2018 - 02.2025
- Responsible for hiring, coaching, and counseling employees.
- Develops and implements internal training for employees – new hires and ongoing training for existing staff.
- Planning, organizing, and managing resources to bring about the successful completion of specific program goals and objectives within the lab, to include recruitment, community outreach, and novel study development.
- Communicates within and across multi-department teams to maximize information sharing.
- Coordinated and documented decisions on new research proposals with the leadership team.
- Prepare summaries of research project status and deliverables for large NIH-funded research trials and industry-sponsored trials.
- Address operational issues related to the running of clinical trials from startup to study close-out.
- Negotiate contracts and budgets during the study-startup phase.
- Monitor costs, expenses, and revenue for clinical trials and develop reports for financial meetings.
- Conduct new study start-up.
- Oversee and manage study close-outs.
- Identify operational process inefficiencies and recommend necessary improvements.
- Function as the primary contact with pharmaceutical sponsors, CROs, professional organizations, and individuals at other research institutions.
- Conducts internal quality check of all clinical research documentation to ensure compliance standards are met.
- Prepare reports of findings, illustrating data graphically, and translating complex findings into written text.
- Collaborate with cross-functional teams to ensure the successful execution of projects in a timely manner.
- Oversee the management of study documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during, and after the conduct of a clinical/translational trial.
- Oversee site visits from sponsors and regulatory authorities.
- Serves as a resource for clinical research staff by maintaining up-to-date knowledge of medical terminology, FDA regulations, ICH guidelines, and Good Clinical Practice.
- Nashville, Tennessee
Clinical Trial Associate
Vanderbilt University Medical Center
Nashville
03.2016 - 04.2018
- Prepared and processed new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional and departmental policies and procedures and federal regulations.
- Prepared and maintained documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during, and after the conduct of a clinical/translational trial.
- Participated in periodic site visits from sponsors, regulatory authorities, and others to review research, source documentation, and research procedures.
- Recorded data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness, and timeliness.
- Addressed query resolution, assured research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice.
- Performed packaging and shipment of study specimens to the sponsor or laboratory.
- Nashville, Tennessee
Research Assistant
Vanderbilt University Medical Center
Nashville
07.2014 - 03.2016
- Recruited research participants into research studies.
- Assessed participants' eligibility for research studies.
- Obtained informed consent from research subjects.
- Scheduled research study visits.
- Conducted clinical interviews.
- Administered cognitive tests.
- Conducted neuroimaging study protocols.
- Checked and maintained data quality.
- Trained and supervised other lab members in data collection and data entry, including students.
- Nashville, Tennessee
Associate Faculty
Nashville State Community College
Nashville
02.2012 - 05.2015
- Developed and implemented instructional strategies to effectively engage students in the learning process.
- Encouraged critical thinking skills by facilitating class discussions among students.
- Employed a variety of methods, including lectures, simulations, debates, and group work for instruction delivery.
- Provided individualized support to ensure student success in completing course requirements.
- Managed administrative tasks such as grading papers and submitting reports.
- Lectured on courses via various media to meet the needs of in-class and remote students.
- Provided feedback to students on the level of performance based on course outcomes.
- Developed syllabuses and course schedules to communicate classroom expectations and learning objectives.
- Nashville, Tennessee
Research Analyst
Vanderbilt University Medical Center
Nashville
10.2010 - 02.2012
- Documented research processes and results through written reports and visualizations for stakeholders' review.
- Gathered primary and secondary data from internal databases and external sources such as public records, reports, and interviews.
- Used statistical software or spreadsheet software to perform statistical analysis.
- Collaborated with cross-functional teams to ensure the successful execution of projects in a timely manner.
- Created database files, maintained records, and assisted in the preparation of materials for publication.
- Edited and/or typed manuscripts according to accepted practices.
- Created informational materials related to research/study for dissemination to study participants, researchers, community.
- Created presentations of study concepts and presented them to the study team and sponsors.
- Nashville, Tennessee
Education
Doctor of Philosophy (Ph.D.) - Psychology
Capella University
Minneapolis, MN, US12.2018
Master of Science (M.S.) - Psychology with an emphasis on counseling
Capella University
Minneapolis, MN, US05.2011
Bachelor of Arts (B.A.) - Psychology
Ashford University
Clinton, IA05.2009
Skills
- Project management and planning
- Contracts and budget oversight
- Cross-functional team collaboration
- Policy development and implementation
- Staff training and development
- Revenue optimization
- Conflict resolution strategies
- Complex problem-solving techniques
- Strategic planning
Timeline
Regulatory Manager
Vanderbilt Ingram Cancer Center
02.2025 - Current
Clinical Trial Research Manager
Vanderbilt University Medical Center
02.2018 - 02.2025
Clinical Trial Associate
Vanderbilt University Medical Center
03.2016 - 04.2018
Research Assistant
Vanderbilt University Medical Center
07.2014 - 03.2016
Associate Faculty
Nashville State Community College
02.2012 - 05.2015
Research Analyst
Vanderbilt University Medical Center
10.2010 - 02.2012
Doctor of Philosophy (Ph.D.) - Psychology
Capella University
Master of Science (M.S.) - Psychology with an emphasis on counseling
Capella University
Bachelor of Arts (B.A.) - Psychology
Ashford University