Carolyn Burke
Clinical Researcher, Emergency Medical Technician
Summary
A relatable and versatile clinical research leader skilled in supporting projects from concept through execution with a reflective and collaborative approach to stakeholders representing diverse perspectives. Experienced in problem-solving, process development and improvement, and professionalism in overcoming challenges.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Associate Director, Clinical Study Management
The Emmes Company
07.2020 - Current
- Assist Senior Director in strategic planning for department
- Contribute to business development proposals and budget strategies
- Serve as department Resource Manager, hiring new staff, evaluating staff skills and expertise, and assigning staff to project teams
- Develop resource management processes and tools
- Evaluate employee retention and implement tools and processes to mitigate retention risks
Project Leader/Clinical Research Manager
The Emmes Corporation
06.2015 - 07.2020
- Served as primary operational contact for study sponsors, senior/principal investigators, and subject matter experts for global trial.
- Ensured compliance with protocol design, competent authority requirements, and Good Clinical Practice (GCP). Implemented and monitor CAPA plans as needed.
- Developed project management plans to define and execute project objectives, timelines, deliverables, and budgets.
- Provided oversight and management, inclusive of timelines, performance, and contract deliverables for vendors supporting drug manufacturing and distribution, clinical supplies, legal representation, site monitoring, country specific regulatory submissions, and language translations.
- Collaborated with team members to develop, identify, and accomplish assigned goals and objectives, examine risks, and coordinate contingency plans.
- Selected and supervised staff teams; offered training, coaching and mentoring; conducted performance reviews, inclusive of measurable goals aligned with staff career goals.
- Resolved conflicts and negotiated mutually beneficial agreements between parties
- Provided ongoing cost and estimate analysis reporting and managed cost allocation
Project Manager
The Emmes Corporation
05.2006 - 06.2015
- Managed several projects supporting neurologic disorder research initiatives
- Created clinical site and patient recruitment plans and implemented strategic initiatives
- Conducted QC review of delegated components of sponsor TMF
- Managed remote and on-site staff, vendor, and client meetings
- Developed SOPs and work instructions
- Promoted projects at numerous professional conferences to increase investigator, patient, and caregiver membership and retention
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts
- Sourced, vetted and managed vendors needed to accomplish project goals
Consultant, Neuroscience and Degenerative Medicine
The Emmes Corporation
03.2010 - 05.2010
- Interviewed investigators to support a series of research projects in traumatic brain injury.
- Devised a recruitment and retention strategy for the Recruitment Core.
Data Manager/Protocol Monitor
The Emmes Corporation
03.2002 - 04.2006
- Developed source documents templates and data collection forms.
- Created electronic case report forms within proprietary software.
- Developed and implemented data queries
- Conducted data integrity and quality review activities
- Managed Ophthalmic Data Management Service Group, allocating resources between projects and implementing training and education initiatives.
- Created clinical protocols and consent documents, and coordinated review by project teams, study investigators, and subject matter experts
- Conducted, qualification, initiation, interim, and closeout site monitoring visits.
- Composed and submitted materials for IRB review
- Compiled and submitted IND applications, and annual, safety, and clinical study reports.
- Served as mentor for new staff and created training and orientation documentation
- Trained site teams in source documentation, HIPAA, protocol compliance, and data compliance
- Developed subject and site team support documents (e.g., diaries, calendars, quick reference sheets)
- Liaised between data management and IT support personnel to communicate ongoing system maintenance and new software development
Education
Bachelor of Science - Health Studies, Public Health
Saint Francis University
LorettoSkills
- Project Management
- Clinical Operations
- Team and Resource Management
- Process Development
- Training and Mentoring
- Troubleshooting and Problem Solving
- Trial Management
- Project Organization
- Resource Management
- Patient Advocacy/Engagement
Therapeutic Highlights
- Neurology - Stroke, TBI, Guillain Barre Syndrome, Epilepsy, Headache, Multiple Sclerosis
- Ophthalmology -Graft vs. Host Disease, Cataracts, Macular Degeneration, Diabetic Retinopathy, Headache, Von Hippel Lindau Disease
- Cardiovascular - Myocardial Infarction, Congestive Heart Failure, Pneumonia
- Alternative Medicine
Accomplishments
- 2013 Emmes Business Development Award
- 2014 Emmes Exemplary Service Award - Leadership Facilitator Team
- 2016-2021 Co-founder and Chairperson of the Emmes Research Recruitment and Retention Team
- 2018 -2019 Steering Committee Member - Emmes Emerging Leaders Mentoring Program
Certification
- Emergency Medical Technician (Maryland, EMT-B)
Community Engagement
Germantown Volunteer Fire Department
- Emergency Medical Technician (MD, EMT-B)
- Vice President/Membership Chair
Publications
1. Shmueli-Blumberg D., Figueroa M., Burke C. (2020) Selection of Study Centers and Investigators. In: Piantadosi S., Meinert C. (eds) Principles and Practice of Clinical Trials. Springer, Cham
2. 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. for the Clinical Research Collaboration , Neurological Emergencies Treatment Trials Network, and the POINT Investigators. July 19, 2018 N Engl J Med 2018; 379:215-225 DOI: 10.1056/NEJMoa1800410
3. 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.
4. Anne S Lindblad, Carolyn Burke , Janice Cordell, Brandy Fureman, Joanne Odenkirchen. The National Institute of Neurological Disorders and Stroke Clinical Research Collaboration (NINDS CRC); Summary of Pilot Activities. Society for Clinical Trials, Vancouver, Canada, 2011.
5. Anne S Lindblad, Tia Patterson, Carolyn Burke , Reggie Sykes, Traci Clemons, Joanne Odenkirchen, Brandy Fureman. 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 2008.
6. Burke C , Lindblad AS. Experiences of the NINDS Clinical Research Collaboration with the use of a Virtual Coordinator. Society for Clinical Trials; 2011; Vancouver, Canada.
7. Lindblad AS, Burke C , Emr M, Odenkirchen J, Koroshetz W, et al. The NINDS CRC: Connecting research to communities by expanding research. American Academy of Neurology; 2009; Seattle, WA.
8. Lindblad AS, King D, Tucker M, Weeks M, Burke C , et al. 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; 2009; Atlanta, GA.
9. Lindblad AS, Patterson T, Burke C , Sykes R, Clemons T, et al. Contributions to racial and ethnic diversity in a genetics repository: National Institute of Neurological Disorders and Stroke Clinical Research Collaboration (NINDS CRC). submitted to SCT2008 December.
10. Lindblad AS, Fureman BE, Burke C , Emr M, Odenkirchen J, et al. The NINDS CRC Chronic Migraine Treatment Trial: Connecting research to communities. submitted to AAN for Annual Meeting 2008 November.
Timeline
Associate Director, Clinical Study Management
The Emmes Company
07.2020 - 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
The Emmes Corporation
03.2002 - 04.2006
Bachelor of Science - Health Studies, Public Health
Saint Francis University
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