Rachel Simon
Clinical Research Manager, CCRC, RN
Charlottesville,VA
Summary
Focused Clinical Research Manager well-versed in study protocols, standard operating procedures, trial oversight, and managing teams. Excellent problem-solving abilities with a detail-oriented nature. Ready to bring over 10 years of related experience to a challenging new role.
Overview
2
2
Certifications
4
4
years of post-secondary education
22
22
years of professional experience
Work History
Clinical Research Manager
University Of Virginia- Department Of Surgery
Charlottesville , VA
05.2019 - Current
- Conducted over 50 clinical trials in phases I-IV, post-market, and emergency/compassionate use across a variety of therapeutic areas including: cardiac surgery, cardiology, vascular surgery, thoracic surgery, pediatric surgery, surgical oncology, general surgery, lung transplantation, heart failure, anesthesia, dermatology, and infectious disease.
- Experience with investigator-initiated, NIH funded, foundational, pharmaceutical, and device protocols from study start-up through study closure.
- Managed a team of 15 clinical research coordinators with a variety of experience levels and licensure.
- Conducted and led hiring searches for the clinical research team
- Performed labor allocation, budgeting, contract negotiations and study feasibility assessments.
- Assisted faculty members with clinical aspects of grant proposals and protocol development.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Managed project risk by identifying, quantifying and monitoring potential threats.
- Maintained knowledge of the Department's strategic direction, goals and objectives and aligned projects appropriately.
Patient Trainer
Acelis Connected Health
Livermore, CA
04.2018 - Current
- Educated patients and their families on the use of a home INR monitoring device and reporting program
- Performed trainings both in-person and virtually
Clinical Data Abstractor
Q-Centrix
Chicago, IL
04.2018 - 09.2019
- Performed remote data abstraction for six different hospital systems for entry into the STS transcatheter registries.
- Utilized a variety of electronic medical records systems, data capture platforms and data dictionaries to meet registry compliance
- Completed quality control checks for other clinical data abstractors
- Worked against hard deadlines to meet the client's timeline and compliance needs
Clinical Research Coordinator- Licensed
University Of Virginia- Department Of Surgery
Charlottesville, VA
01.2011 - 05.2019
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Gathered, processed and shipped lab specimens.
- Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.
- Performed study related nursing tasks (i.e. study drug administration, vital sign collection, phlebotomy)
- Worked with over 18 different data capture systems
- Participated in three different FDA audits
- Acted as Team Lead for the cardiac surgery and vascular surgery study teams. Hired, trained, mentored, and evaluated up to 4 clinical research coordinators at a time.
Registered Nurse, ICU
University Of Virginia
Charlottesville, VA
07.2004 - 12.2010
- Delivered the highest quality care to critically ill patients in the Thoracic Cardio-Vascular Post-Operative Intensive Care Unit
- Remained calm during high-stress, critical situations, demonstrating sustained focus and problem-solving in real-time.
- Precepted student nurses and oriented new hires, providing guidance and mentorship when teaching on hospital policies, emergency procedures and nursing best practices.
- Acted as the unit quality improvement coordinator
- Achieved Clinician III status
Education
Bachelor of Science - Nursing
George Mason University
Fairfax, VA 08.2000 - 05.2004
Skills
Leadership
Certification
Certified Clinical Research Coordinator
Timeline
Clinical Research Manager
University Of Virginia- Department Of Surgery
05.2019 - Current
Patient Trainer
Acelis Connected Health
04.2018 - Current
Clinical Data Abstractor
Q-Centrix
04.2018 - 09.2019
Clinical Research Coordinator- Licensed
University Of Virginia- Department Of Surgery
01.2011 - 05.2019
Registered Nurse, ICU
University Of Virginia
07.2004 - 12.2010
Bachelor of Science - Nursing
George Mason University
08.2000 - 05.2004
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