Lead Clinical Cardiovascular and COVID-19 Research Coordinator/RN
Highly accomplished Registered Nurse and Certified Clinical Research Coordinator with a robust background in cardiovascular and neurodegenerative disease research. Possesses advanced education including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrating a deep understanding of regulatory compliance. Proven expertise in leading complex clinical trials, m...
Experience: 20+ years
Kristin Miller provides regulatory consulting services to clients in:
Boasting a Masters in Jurisprudence with a specialization in Pharmaceutical and Medical Device Law from Seton Hall Law, this candidate possesses a strong legal foundation directly applicable to regulatory affairs in the medical technology sector. Their academic achievements are further complemented by a BSN and specialized certifications in HIPAA and Information Security, underscoring a comprehensive understanding of healthcare regulations and data privacy. This robust educational background provides a unique advantage in navigating the complex legal and regulatory landscapes of medical device and pharmaceutical development.
Recognized as one of the 'Great 100 Nurses in Arkansas,' this candidate's contributions have garnered significant industry acknowledgment. Their status as a published author in esteemed medical journals, including ACC, AHA, and JACC Interventional, further solidifies their position as a thought leader and expert in their field.
While specific professional associations are not detailed, the candidate's involvement in industry-related activities such as serving as an IACRN Abstracts and Project Reviewer, and membership on the IACRN Education Committee and Planning Committee, indicates a strong engagement and recognized contribution within the clinical research nursing community.
A seasoned professional with extensive experience leading high-volume, fast-paced clinical research departments, this candidate has a proven track record in managing all phases of industry and academic trials. Their expertise spans study start-up, protocol development, patient recruitment, and intricate database management within electronic health records. They have successfully managed regulatory submissions, including Emergency Use Authorizations and Single-Use INDs, demonstrating a deep understanding of federal clinical trial programs. Furthermore, their leadership in managing research staff and training investigators highlights significant organizational and team-building capabilities within the research domain.
Highly accomplished Registered Nurse and Certified Clinical Research Coordinator with a robust background in cardiovascular and neurodegenerative disease research. Possesses advanced education including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrating a...
With 20 years of experience, this expert FDA regulatory consultant analyst specializes in medtech, boasting a robust background in cardiovascular and neurodegenerative disease research. Their advanced education, including a Masters in Jurisprudence with a focus on Pharmaceutical and Medical Device Law, demonstrates a deep understanding of regulatory compliance. The consultant's expertise in leading complex clinical trials, managing regulatory submissions, and ensuring adherence to federal clinical trial programs makes them uniquely valuable for medtech companies. Their experience in managing Emergency Use Authorizations, Humanitarian Use Devices, and Single-Use IND submissions showcases their ability to navigate the complex regulatory landscape. Additionally, their technical competencies in clinical trial protocol development, adverse event handling, and ensuring adherence to applicable regulatory rules further solidify their position as a trusted advisor. This consultant's unique combination of FDA experience, device expertise, regulatory depth, and track record makes them an invaluable resource for medtech companies seeking regulatory guidance and submission success.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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