MICHELLE R. AMUNDSON
Dover
Summary
Experienced in team leadership and operational management, with strong organizational skills to optimize workflow and enhance team efficiency. Proven track record of fostering a collaborative work environment that drives the achievement of collective goals.
Overview
32
32
years of professional experience
Work History
Supervisor -Senior Clinical Research Coordinator
Mayo Clinic
03.2023 - Current
- Oversee daily operations, ensuring adherence to safety protocols and quality standards.
- Mentors staff, fostering professional development and enhancing team performance.
- Implement processes improvements that streamlined workflows and increased efficiency.
- Conducts regular performance evaluations, providing constructive feedback to team members.
- Demonstrate commitment to the organization''s core values, leading by example and fostering a culture of excellence.
- Follow clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
Senior Clinical Research Coordinator
Mayo Clinic Comprehensive Cancer Center
02.2022 - 03.2023
- Provide direction and work cooperatively with research fellows and other research staff
- Train, mentor, and supply educational resources to new staff in all disease groups
- Independently direct large, complex, multi-center clinical research protocols/programs in collaboration with the principal investigator and in compliance with regulatory laws and institutional guidelines
- Lead, provide coverage, and support all disease groups
- Maintain compliance with protocols covering patient care and clinical trial operations.
- Participate in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets
Certified Lead Clinical Research Coordinator
Mayo Clinic Cancer Center
08.2021 - 02.2022
- Exercised leadership capabilities for the Lymphoma Disease Group
- Assigned the most complex and challenging trials
- Work effectively in fast-paced environment
- Skilled at working independently and collaboratively in a team environment
- 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
- Followed informed consent processes and maintained records
- 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
Clinical Research Coordinator
Mayo Clinic Cancer Center
08.2015 - 08.2021
- Coordinate complex clinical trials with minimal direction from the Principal investigator or supervisor in compliance with regulatory and institutional guidelines
- These include but not limited to FDA regulated therapeutic clinical trials
- Screens enroll and recruit patients for participation in clinical trials
- Coordinate patient schedules and ensure patient compliance with the protocol test schedule
- Report adverse events and protocol deviations according to protocol and institutional guidelines
- Extract and manage data to maintain quality throughout the study
Associate Clinical Research Coordinator
Mayo Clinic Cancer Center
06.2013 - 08.2015
- Coordinated FDA regulated therapeutic clinical trials
- Prepared and edited study communications
- Identify, enroll, and educate study protocol participants
- Responsible for the accuracy and timeliness of study compliance activities
- Recognize, define, and report adverse events
- Coordinated multi-site clinical trials, ensuring adherence to protocol and regulatory compliance.
- Developed and maintained study documentation, enhancing data integrity and accessibility for stakeholders.
Vascular Access Technician
Mayo Clinic
02.1999 - 06.2013
Laboratory Services Technician
Mayo Clinic
08.1996 - 02.1999
Medical Records Clerk
Mayo Clinic
10.1993 - 08.1996
Education
Bachelor’s - Health Science
American Public University
Charles Town, WV10.2024
Certificate - Clinical Research Certification
Society of Clinical Research Associates - SoCRA
05.2024
Associate - Clinical Research Coordinator
Rochester Community and Technical College
Rochester, MN01.2014
Skills
- Training and mentoring
- Goal oriented
- Staff management
- Customer service
- Attention to detail
- Decision-making
- Complex Problem-solving
- Employee motivation
- Staff development
- Teamwork and collaboration
- Multitasking
- Effective communication
Timeline
Supervisor -Senior Clinical Research Coordinator
Mayo Clinic
03.2023 - Current
Senior Clinical Research Coordinator
Mayo Clinic Comprehensive Cancer Center
02.2022 - 03.2023
Certified Lead Clinical Research Coordinator
Mayo Clinic Cancer Center
08.2021 - 02.2022
Clinical Research Coordinator
Mayo Clinic Cancer Center
08.2015 - 08.2021
Associate Clinical Research Coordinator
Mayo Clinic Cancer Center
06.2013 - 08.2015
Vascular Access Technician
Mayo Clinic
02.1999 - 06.2013
Laboratory Services Technician
Mayo Clinic
08.1996 - 02.1999
Medical Records Clerk
Mayo Clinic
10.1993 - 08.1996
Certificate - Clinical Research Certification
Society of Clinical Research Associates - SoCRA
Associate - Clinical Research Coordinator
Rochester Community and Technical College
Bachelor’s - Health Science
American Public University
Organization
Mayo Clinic, 200 First Street SW, Rochester, Minnesota, 55905, 507-284-2511, mayoclinic.org
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