Senior Clinical Research Associate / Site Manager
Highly accomplished Certified Clinical Research Professional with extensive experience managing Class I-III medical device trials from inception to closure. Proven expertise in site feasibility, study oversight, and ensuring rigorous compliance with GCP, privacy, and regulatory standards. Demonstrates deep knowledge in neuromodulation and cardiovascular specialties, with a strong track record in c...
Experience: 10+ years
Lauren M. DiGiacomo-Tirado provides regulatory consulting services to clients in:
Possesses a strong academic foundation with a Bachelor of Science in Psychology from Canyon College and an Associate of Science in Cardiovascular Sonography from the American College for Medical Careers. Further complemented by specialized certificates in Pharmaceutical Sales, Diver Medic & Hyperbaric Technology, and Emergency Medical Technician training. This diverse educational background underscores a commitment to continuous learning and a broad understanding of healthcare systems, enhancing their capabilities in medical device regulatory affairs.
A member of the Association of Clinical Research Professionals (ACRP), demonstrating a commitment to professional development and industry best practices within the clinical research field. This affiliation highlights engagement with a network of peers and adherence to high professional standards.
A highly accomplished Senior Clinical Research Associate and Site Manager with extensive experience in managing Class I-III medical device research trials. Demonstrated success in site feasibility, study oversight, and adherence to strict compliance, privacy, and regulatory standards across prominent organizations. Proven expertise in neuromodulation and cardiovascular specialties, with a strong ability to manage clinical sites, train investigators, and enhance subject recruitment. Career progression showcases increasing responsibility and a consistent record of driving successful clinical research outcomes in the medtech industry.
Highly accomplished Certified Clinical Research Professional with extensive experience managing Class I-III medical device trials from inception to closure. Proven expertise in site feasibility, study oversight, and ensuring rigorous compliance with GCP, privacy, and regulatory standards. Demonstrat...
With 10 years of experience, Lauren M. DiGiacomo-Tirado is a highly accomplished Senior Clinical Research Associate and Site Manager specializing in Class I-III medical device research trials. Her expertise spans site feasibility, study oversight, and adherence to strict compliance, privacy, and regulatory standards. Lauren's extensive background in neuromodulation and cardiovascular specialties, combined with her ability to manage clinical sites, train investigators, and enhance subject recruitment, makes her uniquely valuable for medtech companies seeking successful clinical research outcomes. Her proficiency in Good Clinical Practice (GCP) for investigational devices, drugs, and medical devices, as well as her experience with various clinical trial management systems (CTMS), Electronic Data Capture (EDC), and Trial Master File (TMF/eTMF) systems, further underscores her strength in regulatory expertise and technical competencies. This consultant's deep understanding of FDA regulations and her proven ability to drive successful clinical research outcomes in the medtech industry make her an exceptional asset for companies seeking to navigate regulatory complexities and ensure data integrity.
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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