Nicole Stoll
4605 Summit Oak Ln,OH
Summary
Dynamic Senior Clinical Research Professional with a proven track record at industry leader, excelling in clinical trial management and team leadership. Expert in ICH-GCP guidelines, I have successfully enhanced study compliance and data integrity while mentoring junior staff, fostering collaboration, and driving process improvements that significantly boosted trial efficiency.
Overview
21
21
years of professional experience
Work History
Senior Clinical Research Associate
Medpace
01.2013 - Current
- Led site selection and initiation activities for multiple clinical trials, ensuring compliance with regulatory requirements.
- Mentored junior associates on study protocols and best practices, enhancing team performance and knowledge retention.
- Developed and implemented monitoring plans to ensure adherence to study timelines and quality standards.
- Collaborated with cross-functional teams to address site-related issues, promoting effective problem-solving strategies.
- Conducted comprehensive site visits to assess study progress and maintain data integrity throughout trial phases.
- Evaluated investigator performance, providing feedback to improve recruitment strategies and patient engagement efforts.
- Facilitated training sessions for new staff on clinical research guidelines, fostering a culture of continuous improvement within the team.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
- Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
Clinical Trial Manager
Medpace
11.2011 - 05.2013
- Led cross-functional teams to develop and execute clinical trial protocols.
- Managed project timelines, ensuring adherence to regulatory requirements and quality standards.
- Coordinated investigator meetings and site initiation visits to facilitate study start-up activities.
- Monitored trial progress, identifying risks and implementing mitigation strategies proactively.
- Developed training materials for staff on clinical trial processes and compliance guidelines.
- Oversaw budget management, ensuring optimal resource allocation across multiple projects.
- Collaborated with data management teams to ensure accurate and timely data collection and analysis.
- Developed training materials for site staff to enhance their understanding of the study protocol, resulting in improved adherence to requirements.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Spearheaded the selection of appropriate clinical sites by conducting thorough feasibility assessments based on predefined criteria.
- Contributed to protocol development, ensuring a well-designed study that met research objectives while adhering to ethical standards and regulations.
Clinical Research Associate
Medpace
11.2004 - 10.2010
- Coordinated and monitored clinical trial activities to ensure compliance with regulatory requirements.
- Developed and maintained study documentation, including protocols, informed consent forms, and case report forms.
- Conducted site visits to assess performance, ensuring adherence to study timelines and quality standards.
- Collaborated with cross-functional teams to resolve issues impacting trial execution and patient recruitment.
- Implemented process improvements that enhanced data accuracy and streamlined reporting procedures.
Education
Bachelor of Science - Biological Sciences
Wright State University
Dayton, OH05-2022
Master of Science - Clinical Research
The George Washington University
Washington, DC05-2011
Skills
- Team leadership
- Clinical trial management
- Site management
- Clinical study design
- Study documentation mastery
- Site monitoring expertise
- ICH-gCP guidelines
- Good clinical practices
- Study protocols
- Trial management
- Documentation requirements
- Teamwork and collaboration
- Leadership skills
- Quality assurance techniques
Timeline
Senior Clinical Research Associate
Medpace
01.2013 - Current
Clinical Trial Manager
Medpace
11.2011 - 05.2013
Clinical Research Associate
Medpace
11.2004 - 10.2010
Bachelor of Science - Biological Sciences
Wright State University
Master of Science - Clinical Research
The George Washington University