Amy Muchinsky
Danvers,MA
Summary
Clinical research professional with extensive experience at Emory University School of Medicine and various pharmaceutical and medical device sponsors. Specializes in regulatory compliance and strategic planning, enhancing operational efficiency and communication. Proven ability to develop innovative solutions that drive successful project outcomes, while ensuring adherence to health authorities and regulatory agencies.
Overview
31
31
years of professional experience
Work History
Marketing Specialist
Vivat Construction Sales
Newton, Massachusetts
05.2025 - Current
- Formulated comprehensive marketing strategies to boost brand visibility and engagement.
- Analyzed market trends to identify opportunities for product positioning and promotion.
- Creation of digital content across multiple platforms to enhance online presence.
- Generated innovative ideas to drive sales through creative promotional campaigns.
Clinical Research Operations Manager
Emory University School of Medicine
Atlanta , GA
08.2018 - 05.2025
- Coordinated research operations across various projects and departments to enhance efficiency.
- Facilitated communication among researchers, staff, and external partners to ensure alignment.
- Implemented process improvements that streamlined research workflows significantly.
- Collaborated with external partners to synchronize joint research initiatives effectively.
- Ensured compliance with applicable regulations governing all research activities.
- Developed regulatory strategies for successful product submissions and approvals.
- Prepared submission documents for health authorities and regulatory agencies systematically.
- Managed regulatory projects from initiation through to successful completion.
Clinical Research Consultant
Bakken Research Center/ Medtronics
Frederick, Maryland
03.1997 - 08.2018
- Developed clinical research protocols for innovative healthcare solutions.
- Coordinated training sessions on Good Clinical Practices and other clinical research topics.
- Conducted site visits to ensure trial progress and compliance with protocols.
- Analyzed research data to guide decision-making and project direction.
- Facilitated effective communication among stakeholders and external partners.
- Participated in investigator meetings to review trial objectives and safety monitoring procedures.
- Managed multiple projects from initiation to completion, adhering to timelines.
- Collaborated with cross-functional teams to enhance research processes.
Senior Clinical Research Associate
North American Biologicals, Inc.
Rockville, Maryland
01.1996 - 03.1997
- Led clinical trial protocols, ensuring compliance with regulatory guidelines.
- Managed site selection and monitored investigator performance during trials.
- Coordinated communication between sites, sponsors, and regulatory agencies to enhance collaboration.
- Conducted pre-study, closeout, and interim visits to evaluate study activities.
- Tracked study-specific trial management tools and systems for efficiency.
- Organized investigator meetings, prepared minutes, and tracked resulting action items.
- Assisted with preparation for FDA inspections as required.
Clinical Research Associate
Otsuka Pharmaceuticals, Inc.
Rockville, MD
01.1995 - 01.1996
- Executed site visits to verify compliance with study protocols and regulatory guidelines.
- Monitored patient recruitment and retention during clinical trials to enhance participation.
- Conducted training sessions for site staff on clinical trial procedures and expectations.
- Performed pre-study evaluations, site initiations, interim monitoring, and close-out visits.
- Collected and reviewed regulatory documentation to ensure adherence to standards.
- Analyzed data for accuracy prior to database lock and identified discrepancies as needed.
- Delivered GCP standards training to new personnel and existing staff members.
Education
Bachelor of Science - Neuroscience/Psychology
Washington State University
Pullman, WA06-1994
Paralegal Certifications - Law
University of Texas
Austin, TX06-2013
DMID, CITI, EHSO And NIH Certifications - Good Clinical Practices
CITI Program
RAC Certification - Medical Device and Pharmaceutical
Regulatory Affairs Professional Society (RAPS)
Skills
- Medical device, pharmaceutical, and biotechnology experience
- Broad therapeutic trial exposure
- Submission preparation
- Audit surveillance
- Effective communication skills
- Strategic planning
- Attention to detail
- Phase I-IV research and development
- Global regulatory compliance
- Project management
- Clinical trial oversight
- Team leadership
References
References available upon request.
Timeline
Marketing Specialist
Vivat Construction Sales
05.2025 - Current
Clinical Research Operations Manager
Emory University School of Medicine
08.2018 - 05.2025
Clinical Research Consultant
Bakken Research Center/ Medtronics
03.1997 - 08.2018
Senior Clinical Research Associate
North American Biologicals, Inc.
01.1996 - 03.1997
Clinical Research Associate
Otsuka Pharmaceuticals, Inc.
01.1995 - 01.1996
Bachelor of Science - Neuroscience/Psychology
Washington State University
Paralegal Certifications - Law
University of Texas
DMID, CITI, EHSO And NIH Certifications - Good Clinical Practices
CITI Program
RAC Certification - Medical Device and Pharmaceutical
Regulatory Affairs Professional Society (RAPS)