Open To Work
CAROLYN BURKE, EMT
Work Preference
Summary
Dedicated leader with a proven ability to drive project success through strategic planning, meticulous oversight, and effective collaboration with cross-functional teams. Known for adeptly navigating challenges to deliver results, I am committed to advancing healthcare through the translation of research into practice care standards.
Overview
24
24
years of professional experience
Work History
Research Regulatory Coordinator
TidalHealth-Richard A. Henson Research Institute
07.2025 - Current
- Prepares, submits, and maintains regulatory documentation for clinical trials ensuring ongoing compliance with federal and institutional regulations and policies
- Advises research teams on compliance with human subjects research protection laws, regulations, ethical standards, and institutional policies
- Facilitates protocol and regulatory compliance training for facility research teams
- Coordinates and tracks research team training, supporting contemporaneous records, and compliance with research regulations and guidelines
- Developed and deployed tools for documenting subject safety events and study deviations
- Collaborates with study investigators and sponsor teams, providing regulatory support and ensuring timely resolution of compliance-related issues
Emergency Medical Technician
Germantown Volunteer Fire Department
04.2018 - Current
- Treasurer, Board of Directors
- Chairperson, Recruitment and Retention Committee
Associate Director, Clinical Trial Management and Monitoring (CTMM)
The Emmes Company
06.2023 - 01.2024
- Facilitated integration activities between two departments comprising 150 staff; supporting change management activities
- Successfully completed over 50 staff resourcing assignments
- Assisted senior leadership in managing all department operations
- Provided leadership to teams of up to ten clinical trial managers and implemented career development plans, resulting in improved performance and achievement of department and project objectives.
Associate Director, Clinical Study Management (CSM)
The Emmes Company
07.2020 - 06.2023
- Played a key role in creating a new department of 65 staff, demonstrating strategic planning and organizational skills.
- Developed and implemented resource management processes and tools, enhancing operational efficiency and resource utilization.
- Evaluated employee retention and implemented effective tools and processes to mitigate retention risks, resulting in improved staff retention rates despite significant corporate restructuring.
- Contributed to business development proposals and budget strategies
- Served as line manager for Managers, Clinical Study Management
Project Leader/Clinical Research Manager
The Emmes Corporation
06.2015 - 07.2020
- Managed a multi million-dollar budget, consistently meeting financial targets
- Served as primary operational contact for study sponsors, senior/principal investigators, and subject-matter experts for a global trial.
- Provided oversight and management of vendors supporting drug manufacturing and distribution, clinical supplies, legal representation, site monitoring, country specific regulatory submissions, and language translations.
- Supervised teams of up to 30 staff across clinical operations providing training, coaching, and mentoring resulting in improved performance and career advancement
Project Manager
The Emmes Corporation
05.2006 - 06.2015
- Managed 3 large projects supporting neurologic disorder research programs
- Developed project management plans, leading to successful execution of project objectives, timelines, and deliverables within budget.
- Created clinical site and patient recruitment plans and implemented strategic initiatives
- Developed SOPs and work instructions at project and corporate levels
- Promoted projects at professional conferences to increase investigator, patient, and caregiver membership and retention resulting in over 600 additional members.
- Sourced, vetted, and managed vendors needed to accomplish project goals
- Conducted interim and close-out monitoring visits, as needed
- Ensured compliance with protocol design, competent authority requirements, and Good Clinical Practice (GCP). Implemented and monitored CAPA plans as needed.
- Initiated and led a corporate group supporting patient recruitment and engagement strategies
Consultant, Neuroscience and Degenerative Medicine
The Emmes Corporation
03.2010 - 05.2010
- Interviewed study investigators to support a series of research projects in traumatic brain injury.
- Devised a patient recruitment and retention strategy for the Recruitment Core.
Data Manager/Protocol Monitor (CRA)
The Emmes Corporation
03.2002 - 04.2006
- Developed source document templates and collection forms reducing risk of undocumented study activities
- Created electronic case report forms and conducted data integrity and quality review activities.
- Developed clinical protocols and consent documents with consideration for both the patient experience and site operational flow.
- Conducted qualification, initiation, interim, and closeout site monitoring visits
- Successfully worked with non-compliant sites to achieve compliance and improved performance.
- Developed standard operating procedures (SOPs), clinical monitoring plans, and other ancillary manuals.
- Composed and submitted materials for IRB review
- Compiled and submitted IND applications, and annual, safety, and clinical study reports.
- Developed subject and site team support documents (e.g., diaries, calendars, quick reference sheets)
Education
Bachelor of Science - Health Studies, Public Health
Saint Francis University
Loretto, PennsylvaniaSkills
- Project Management and Organization
- Clinical Trial Operations
- Resource and Line Management
- Process Development
- Troubleshooting and Problem Solving
- Participant Recruitment and Engagement
- Vendor Selection and Management
- Training and Mentoring
Accomplishments
- 2018-2019, Steering Committee Member, Emmes Emerging Leaders Mentoring Program
- 2016-2021, Co-founder and Chairperson of the Emmes Research Recruitment and Retention Team
- 2014, Emmes Exemplary Service Award - Leadership Facilitator Team
- 2013, Emmes Business Development Award
Publications
- Shmueli-Blumberg D., Figueroa M., Burke C., 2020, Selection of Study Centers and Investigators., Piantadosi S., Meinert C. (eds) Principles and Practice of Clinical Trials., Springer, Cham
- S. Claiborne Johnston, M.D., Ph.D., J. Donald Easton, M.D., Mary Farrant, M.B.A., William Barsan, M.D., Robin A. Conwit, M.D., Jordan J. Elm, Ph.D., Anthony S. Kim, M.D., Anne S. Lindblad, Ph.D., and Yuko Y. Palesch, Ph.D., 2018, N Engl J Med, 379, 215-225, 10.1056/NEJMoa1800410
- Weaver LK, Wilson SH, Lindblad AS, Churchill S, Deru K, Price R, Williams C, Orrison WW, Walker J, Meehan A, Mirow S and the BIMA Study Team., 2018, A randomized trial of hyperbaric oxygen in U.S. service members with post-concussive symptoms., Undersea and Hyperbaric Medical Society Journal, 45, 129-156
- Anne S Lindblad, Carolyn Burke, Janice Cordell, Brandy Fureman, Joanne Odenkirchen., 2011, The National Institute of Neurological Disorders and Stroke Clinical Research Collaboration (NINDS CRC); Summary of Pilot Activities., Society for Clinical Trials, Vancouver, Canada
- Anne S Lindblad, Tia Patterson, Carolyn Burke, Reggie Sykes, Traci Clemons, Joanne Odenkirchen, Brandy Fureman., 2008, Contributions to Racial and Ethnic Diversity in a Genetics Repository: National Institute of Neurological Disorders and Stroke Clinical Research Collaboration (NINDS CRC)., Submitted to SCT, December
- Burke C, Lindblad AS., 2011, Experiences of the NINDS Clinical Research Collaboration with the use of a Virtual Coordinator., Society for Clinical Trials, Vancouver, Canada
- Lindblad AS, Burke C, Emr M, Odenkirchen J, Koroshetz W, et al., 2009, The NINDS CRC: Connecting research to communities by expanding research., American Academy of Neurology, Seattle, WA
- Lindblad AS, King D, Tucker M, Weeks M, Burke C, et al., 2009, Lessons learned from the launch of a simple randomized trial in chronic migraine: National Institute of Neurological Disorders and Stroke Clinical Research Collaboration (NINDS CRC)., Society for Clinical Trials, Atlanta, GA
- Lindblad AS, Patterson T, Burke C, Sykes R, Clemons T, et al., 2008, Contributions to racial and ethnic diversity in a genetics repository: National Institute of Neurological Disorders and Stroke Clinical Research Collaboration (NINDS CRC)., submitted to SCT, December
- Lindblad AS, Fureman BE, Burke C, Emr M, Odenkirchen J, et al., 2008, The NINDS CRC Chronic Migraine Treatment Trial: Connecting research to communities., submitted to AAN for Annual Meeting, November
Personal Information
Title: EMT
Therapeutic Highlights
- Neurology - Stroke, TBI, Guillain Barre Syndrome, Epilepsy, Headache, Multiple Sclerosis
- Ophthalmology - Graft vs. Host Disease, Cataracts, Macular Degeneration, Diabetic Retinopathy, Von Hippel Lindau Disease
- Cardiovascular - Myocardial Infarction, Congestive Heart Failure
- Respiratory - Pneumonia
Community Service
Germantown Volunteer Fire Department, 04/01/18, Emergency Medical Technician (Maryland), Vice President, Board of Directors, Chairperson, Recruitment and Retention Committee
Affiliations
Emergency Medical Technician (Maryland)
Treasurer, Board of Directors, Germantown Volunteer Fire Department
Treasurer, Board of Directors, Germantown Volunteer Fire Department
Timeline
Research Regulatory Coordinator
TidalHealth-Richard A. Henson Research Institute
07.2025 - Current
Associate Director, Clinical Trial Management and Monitoring (CTMM)
The Emmes Company
06.2023 - 01.2024
Associate Director, Clinical Study Management (CSM)
The Emmes Company
07.2020 - 06.2023
Emergency Medical Technician
Germantown Volunteer Fire Department
04.2018 - Current
Project Leader/Clinical Research Manager
The Emmes Corporation
06.2015 - 07.2020
Consultant, Neuroscience and Degenerative Medicine
The Emmes Corporation
03.2010 - 05.2010
Project Manager
The Emmes Corporation
05.2006 - 06.2015
Data Manager/Protocol Monitor (CRA)
The Emmes Corporation
03.2002 - 04.2006
Bachelor of Science - Health Studies, Public Health
Saint Francis University