Generative Artifical Intelligence
Kelvin Peek
Rochester,New York
Summary
Experienced Regulatory Affairs Analyst With a robust chemistry background and a track record of enhancing clinical trial efficiency through generative AI tools. Adept at data-driven decision-making and project management and keen to contribute to Outlier (Scale AI), a frontrunner in AI model training. Aligns with Outlier's mission to revolutionize AI with high-quality data, aiming to drive innovation alongside San Francisco's finest team of AI and software experts.
Overview
13
13
years of professional experience
8
8
Certificate
Work History
Feasibility Analyst (Contracted)
Sylvester Comprehensive Cancer Center at University of Miami/Actalent
11.2022 - 05.2023
- Initiated over 30 Phase 1-3 clinical trials, increasing protocol approval rates by 85% within six months. Employed generative AI to automate and refine the creation of comprehensive feasibility reports, enhancing the precision and depth of analysis, and demonstrating a significant impact on trial initiation efficiency.
- Attained a 100% success rate in site selection by completing more than 30 in-depth feasibility questionnaires. Integrated generative AI to process and analyze large datasets, enabling precise evaluation and reporting of essential metrics including patient accrual, gene types, site logistics, and financial factors. This ensured the selection of the most appropriate sites for diverse studies.
- Achieved a 25% reduction in study delays through adept scope and schedule management, employing techniques like crashing and schedule compression, complemented by effective stakeholder engagement and consistent status updates with the Protocol Review and Monitoring Committee (PRMC) subcommittee
- Achieved a 25% reduction in study delays through adept scope and schedule management, employing AI-powered forecasting and predictive analysis. Techniques like crashing and schedule compression were enhanced with AI algorithms, complemented by effective stakeholder engagement and consistent status updates with the Protocol Review and Monitoring Committee (PRMC) subcommittee.
- Assessed and presented feasibility findings to the Medical Director of the PRMC. Utilized generative AI to refine and personalize over 20 subcommittee letters to top oncologists in the U.S., showcasing effective communication and influential reporting skills.
- Employed tools like Power BI to create visual representations of trial data. This helped in identifying patterns and trends crucial for decision-making and strategy development in clinical trials.
- Utilized specialized software integrated with generative AI to extract and analyze data from clinical trial databases more efficiently. This ensured alignment with specific research criteria, enhancing the accuracy and depth of feasibility assessments.
- Employed tools like Power BI, augmented with AI capabilities, to create dynamic visual representations of trial data. This AI-enhanced approach helped in identifying patterns and trends crucial for decision-making and strategy development in clinical trials.
- Utilized advanced data analysis tools, incorporating AI algorithms for genetic testing data evaluation. This facilitated a more nuanced interpretation of clinical trial data, aiding in accurate feasibility assessments and strategic decision-making.
- Generated reports and presentations using AI tools to ensure clarity and impact. Leveraged generative AI to tailor communication, ensuring that complex data is presented in an understandable and actionable manner to team members and stakeholders, enhancing the decision-making process for trial feasibility and potential outcomes.
Regulatory Study Startup Coordinator (Contracted)
Dartmouth-Hitchcock Medical Center
10.2021 - 06.2022
- Drafted and revised 10+ informed consent documents within 9 months, enhancing compliance and patient understanding in Phase I-IV trials
- Reduced study start-up timelines by 15% through collaboration with IRB and implementing efficient document management systems
- Maintained 100% compliance with site-specific SOPs and regulatory requirements across assigned cancer trials
- Optimized study start-up processes by coordinating with cross-functional teams, Institutional Review Board (IRB) associates, and clinical site staff
- Managed and ensured compliance with regulatory documents, applying healthcare standards like ICD-10 and SNOMED CT in investigational new drug (IND) applications required for FDA approval.
- Demonstrated proficiency in utilizing CTMS OnCore for trial management, ensuring seamless coordination and data integrity
- Skilled in eRegulatory systems, particularly eReg, for maintaining accurate and compliant regulatory documentation
- Streamlined regulatory processes and enhanced communication flow using OnCore and eReg, contributing to improved study efficiency and team collaboration
- Actively involved in the integration of eReg with OnCore, facilitating a unified approach to study management and regulatory compliance.
Regulatory Coordinator (Maintenance)
James P Wilmot Cancer Center
11.2018 - 03.2021
- Led regulatory oversight for 15+ Genitourinary Investigator-Initiated Trials, achieving 100% compliance with FDA and local IRB regulations, demonstrating effective management and adherence to stringent standards
- Implemented a meticulous ALCOA+ compliant documentation process for 50+ clinical studies, enhancing data integrity and ensuring adherence to best practices in regulatory maintenance
- Collaborated with site leadership to prepare for 30+ monitoring visits, conducting thorough quality checks of regulatory binders to ensure compliance and readiness
- Directed regulatory compliance initiatives for ongoing clinical studies, ensuring 100% adherence to IRB, FDA, and other regulatory bodies' standards, significantly reducing risk of non-compliance
- Efficiently managed and expedited the submission process for over 100 protocol amendments, annual reviews, and adverse event reports, achieving a 95% on-time submission rate to the IRB
- Expertly drafted and revised informed consent documents for 85+ Phase I-IV trials, aligning with 21 CFR Part 50 and IRB requirements, thus enhancing participant understanding and regulatory adherence
- Efficiently maintained 100+ study binders, leveraging e-Regulatory system Complion, to ensure compliance with 21 CFR Part 11 and maintain audit-readiness, demonstrating proficiency in regulatory technology
- Drafted and revised initial and ongoing informed consent documents for 85+ Phase I-IV trials, ensuring regulatory compliance per 21 CFR Part 50 and local IRB requirements
- Maintained comprehensive study binders, both paper and electronic, using e-Regulatory system (Complion) always ensuring compliance with 21 CFR Part 11, their accuracy and audit-readiness
- Oversaw the training status of new/existing staff, ensuring all team members were up-to-date with required research documentation and protocol training
- Led query resolution activities in Interim/Remote Monitoring Visits (IMV/RMV), enhancing investigator oversight.
- Managed and updated clinical trial data in the Clinical Trial Management System, aligning with Cancer Center Support Grant (CCSG) data requirements.
- Coordinated data collection and reporting for CCSG, ensuring adherence to specific grant metrics and benchmarks.
- Implemented tracking systems within the CTMS for monitoring activities related to the Cancer Center Support Grant, emphasizing data accuracy and attention to detail.
- Integrated diverse data sources into the CTMS, providing comprehensive and updated information essential for Cancer Center Support Grant reporting.
Healthcare Specialist (68W)
US Army
04.2010 - 04.2014
- Provided first aid and life support to over 100 individuals in prehospital settings, maintaining a 100% service record
- Ensured 100% readiness of ambulance inventory, managing equipment, and medication restocking
- Administered critical medical exams and treatments, achieving 100% soldier readiness in field operations
- Conducted field tests and administered medication, stabilizing patients in transit.
Skills
- Analytical Chemistry
- Biochemistry
- Big Data
- Business Intelligence Tools (SAS, SSRS, Cognos, Tableau, Excel)
- Collaborative Communication
- Customer Service
- Data Analysis
- Data Science
- Generative Artificial (AI)
- Healthcare Analytics
- Independent Working
- Inorganic Chemistry
- Machine Language (ML)
- Organic Chemistry
- Organizational Skills
- Physical Chemistry
- Problem-Solving
- Prompt Engineering
- Risk Modeling (AGC)
Certification
- Six Sigma Yellow Belt, University System of Georgia on Coursera - September 2023
- Prompt Engineering for ChatGPT, Coursera- September 2023
- ChatGPT Advanced Data Analyst, Coursera- September 2023
- ChatGPT AI Primer, Coursera - September 2023
- Generative AI for Leaders, Coursera - September 2023
- Good Clinical Practice (U.S. FDA Focus), CITI Program - October 2021
- Biomedical Research - Basic/Refresher, CITI Program - October 2021
- Biomedical Responsible Conduct of Research, CITI Program - October 2021
Education
Project Management Professional (PMP) -
Project Management Institute (PMI)
Ithaca, NY01.2024
Certificate in Project Management -
Cornell University
Ithaca, NY11.2023
Master of Science - Health Administration
United States Roberts Wesleyan College
Rochester, NY05.2023
Associate of Science - Health Administration
United States Monroe Community College - Rochester, NY
Rochester, NY01.2018
Bachelor of Science - Chemistry
United States Rochester Institute of Technology
Rochester, NY06.2004
Timeline
Feasibility Analyst (Contracted)
Sylvester Comprehensive Cancer Center at University of Miami/Actalent
11.2022 - 05.2023
Regulatory Study Startup Coordinator (Contracted)
Dartmouth-Hitchcock Medical Center
10.2021 - 06.2022
Regulatory Coordinator (Maintenance)
James P Wilmot Cancer Center
11.2018 - 03.2021
Healthcare Specialist (68W)
US Army
04.2010 - 04.2014
Project Management Professional (PMP) -
Project Management Institute (PMI)
Certificate in Project Management -
Cornell University
Master of Science - Health Administration
United States Roberts Wesleyan College
Associate of Science - Health Administration
United States Monroe Community College - Rochester, NY
Bachelor of Science - Chemistry
United States Rochester Institute of Technology
- Six Sigma Yellow Belt, University System of Georgia on Coursera - September 2023
- Prompt Engineering for ChatGPT, Coursera- September 2023
- ChatGPT Advanced Data Analyst, Coursera- September 2023
- ChatGPT AI Primer, Coursera - September 2023
- Generative AI for Leaders, Coursera - September 2023
- Good Clinical Practice (U.S. FDA Focus), CITI Program - October 2021
- Biomedical Research - Basic/Refresher, CITI Program - October 2021
- Biomedical Responsible Conduct of Research, CITI Program - October 2021
Affiliations
- Association of Clinical Research Professionals (ACRP)
- Project Management Institute (PMI)
- Regulatory Affairs Professionals Society (RAPS)
- Society for Human Resource Management (SHRM)
- Society of Clinical Research Associates (SOCRA)
Groups
- Association of Clinical Research Professionals (ACRP)
- Society of Clinical Research Associates (SOCRA)
- Project Management Institute (PMI)
- Society for Human Resource Management (SHRM)
Software
Clinical Trial Management Systems (CTMS)
Electronic Regulatory Systems
Electronic Institutional Review Board (IRB) Systems
Power BI
Tableau
Personal Information
- Military Service Branch: United States Army
- Military Service Rank: E-4
Quote
The ones who are crazy enough to think they can change the world, are the ones that do.
Steve Jobs
Work Preference
Work Type
Full TimePart TimeContract WorkInternshipWork Location
RemoteHybridImportant To Me
Career advancementWork-life balancePersonal development programsWork from home optionTeam Building / Company RetreatsCompany CultureSimilar Profiles
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