Regulatory & Clinical Affairs Executive, PM/IRB Expert

Carol Pasquarella Mitchell, ACRP-PM, RRT-NPS, RPFT

Regulatory & Clinical Affairs Executive IND/IDE/510(k)/PMA Expert IRB Review Board

New York City Metropolitan Area 203-***-**** *************@*****.*** linkedin.com/in/carolmitchellacrppm

Professional Summary

Forward-thinking Clinical and Regulatory Affairs Executive with over 25 years of experience leading global clinical development and regulatory strategy for pharmaceutical, medical device, and biologic products. Expert in trial design, regulatory submissions (IND, IDE, 510(k), PMA), CRO/vendor oversight, and FDA engagement. Board-appointed IRB member and cross-functional team leader with credentials in five medical and two regulatory specialties.

Core Competencies & Certifications

•Project Manager (ACRP-PM) Association of Clinical Research Professional-Project Manager (2022)

•Certified Clinical Research Professional (CCRP) -Association of Clinical Research Professionals (2020)

•Regulatory Submissions (IDE, 510(k), PMA)

•FDA Small Business Designation Filing

•FDA Facility and Product License and Product Registrations

•GUDID Assignment

•FDA Userfee Filing

•FDA Health Canada Medical Device and Facility License and Registrations

•Clinical Development Strategy (Phase I–IV)

•FDA/EMA Engagement & Meeting Leadership

•Trial Design, Data Management, Safety Monitoring

•Quality Management Systems (QMS), GCP, ICH, ISO14155

•Cross-Functional Leadership & Vendor Oversight

•Certifications: RRT, RRT-NPS, CRTT, CPFT, RPFT, ACRP-PM

Honors & Publications

Appointed Board Member – Scientific Unaffiliated Institutional Review Board (Yale University)

Select Publications:

• Use of Exhaled Nitric Oxide in Assessment of Adherence in Inner-City Asthma Clinics

• NT-proBNP for Detection of Cardiovascular Stress in Obstructive Sleep Apnea

• Sleep Deprivation and Off-Duty Activities in Medical Interns

• Comparison of FEV6 and FVC for Detecting Airway Obstruction

• Effectiveness of Low Dose CT Scanning for Lung Cancer Screening

Clinical Trial Operations and Regulatory Specialist

RegenLab USA – Jersey City, NJ Nov 2022 – Present

Report to CEO-Variable <40hr/week

Lead global clinical strategy and regulatory filings for US and Canadian markets.

Designed protocols and EDC systems supporting IDE, PMA, and 510(k) submissions.

Clinical Trial Manager-oversee local monitors and CRO activity, QMS, and vendor oversight; conducted UAT on trial specific ECD systems.

Oversee Site activity, serve as point of contact for Investigators, resolve escalated issues.

Manage IRB submissions for Sponsor and oversee site submissions

Ensure Site effectively communicate with Data Management for query

Ensure clinical trial agreements (CTA) and budgets are finalized and in effect

Oversees site payments

Create and manage Sponsor and Site regulatory files

Sr. Clinical Project Manager

Care Access Research – Remote Sep 2020 – Sep 2022

Report to VP of Clinical Operations-Variable time 20-40hr/week

Managed large Covid studies under rapid expansion, tight deadlines and an excessive large team of monitors, CROs and independently contracted coordinators.

Conducted site feasibility

Created weekly reports for Sponsors

Managed escalation pathways for data management issues

Built quality frameworks, SOPs, and workflows for decentralized trial protocols.

Created internal tools and operational plans that drove higher protocol adherence.

Executive Consultant, Clinical Affairs

Zepto Life Technology – North America/Asia Jan 2022 – Sep 2022

Report to COO-<10hr per week

Designed CRO subsidiary framework and clinical infrastructure within internal software.

Developed TMFs, SOPs, and onboarding programs to accelerate operational launch.

Senior SME Consultant Regulatory Affairs & Quality

Confinis – Switzerland (Remote) Aug 2020 – Sep 2022

Report to Project Lead-<5hr/week

Advised global regulatory strategy for medical devices, IVDs, and combination products.

Led compliance audits, submission filings, and regulatory gap analysis.

Clinical Trial Manager

PRP Concepts 2018-2022

Report to Founder-Small Project-One Class II Medical Device- <20hr/week

Spearhead full-scope clinical trial operations spanning protocols, budget negotiations, start-up planning, contract administration, CTAs, NDAs, and monitoring plans,

Determine site feasibility, recruit study subjects, design case report forms, create ISF, prepare investigator site files, and forge cooperative relationships between investors and clinical site to achieve high-impact outcomes in alignment with rigorous ICH and Good Clinical Practice guidelines.

Develop data capture database, and train site staff on protocol conduct and data capture compliance.

Foster positive vendor relationships to establish efficient and reliable supply chain, and to ensure accuracy of product labeling and packaging.

Supervise three trials across 10+ sites, with occasional onsite 2nd level monitoring as needed.

Ensure billing compliance and generate trial reports for data analysis and Data Safety Monitoring Board.

Clinical Research Project Manager

Fairfield County Foot Surgeons, 2009 to 2018

Report to Practice Founder

Championed pharmaceutical research activity for private practice, with critical accountability for establishing policies to ensure stringent compliance with FDA, GCP, and ICH requirements.

Oversaw data management, budgeting, contracts, resource management, and all documentation.

Director of Clinical Education and Research

Norwalk Hospital, 1998 to 2009

Report to Chief Medical Officer

Led all academic and industry research for hospital and clinics while ensuring seamless and timely communication among clinical sites to drive successful program development and outcomes.

Recruited subjects, oversaw informed consents, created source documents and regulatory documents, managed clinical trial data, handled SAE reporting, and diligently maintained drug accountability.

Administered pulmonary function testing, conducted ECGs, and efficiently obtained, processed, and shipped lab specimens according to IATA standards.

Attended and participated in sponsor evaluation, monitoring, and closeout visits.

Prior Background

Supervisor, Department of Pulmonary Medicine, Sunrise Senior Living

Trauma, Critical Care and Continued Care Staff Therapist/Pulmonary Function Lab Technologist/Hyperbaric Therapy Specialist/Community Health Clinic Respiratory Therapist/Polysomnographer, Greenwich Hospital, Norwalk Hospital

Education

Post Grad Certificate Leadership in Management-Yale University School of Management (2022)

Bachelors of General Studies - University of Connecticut (2005)

Respiratory Care Practitioner – Connecticut State College (1998)

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