Carol Pasquarella-Mitchell

Under the CEO and VP of Operations, Lead the company's expansion to add a subsidiary of Clinical
Research Orginazation to their current service offerings.
Designed the department's operational structure, operational manuals, and file templates such as trial
master files, investigator profiles, site management, trial supplies, and branding material.
Guided their hiring process to fill essential roles.
Created training programs and materials for the company's leadership, new hires, role-specific
onboarding, and site activation

Create FDA/NIOSH submission approach for approval of drugs, devices, and biologics of NDA, IND,
ANDA, 510K.
Created FDA reply to submission responses.
Perform gap analysis and review for regulatory compliance
Constructed protocols, application, and direction of the regulatory approach to obtain market approval.

Conducted company feasibility, analysis, and strategic approach process on prospective clinical trials
sourced by their Business Development Department.
Created operational framework, process flows, and turn-by-turn workflows for specific protocol
implementation throughout company operations.
Responsible for collecting and analyzing internal and external data to influence and inform protocol
development and operational plans.
Advised on the creation of their Quality Management System.
Carol Pasquarella Mitchell, ACRP-PM - page 1
Responsible for the creation of trial-specific Manual of Operations and handoff to the Clinical Trial
Managers for execution.
Managed decentralized clinical research coordinators through a time of rapid growth from a team of 20
to 80 direct reports. Managed deployments

• Design and advise on clinical development activities for marketing FDA and 510k approval
• Development of trial design, financial forecasting, and budgets and contract.

• Lead the recruitment and retention strategy for assigned projects
• Collaborate with feasibility team on early planning
• Provide project team support to ensure the implementation of patient recruitment, retention principles, and tools
• Support and coach Project Managers in implementing aspects of their Patient Recruitment and
• Retention plan
• Rework aspects of strategic patient recruitment and retention plan at times when project intervention is deemed necessary
• Support internal and client-facing meetings regarding patient recruitment on strategies, capabilities, and study updates.

• Developed recruitment strategies to ensure that studies consistently met their recruitment goals
• Provided direction and support for the site team to ensure that the recruitment plans were followed and provided support to help them meet their goals
• Developed metrics to track site progress
• Metrics were routinely shared with sponsors to demonstrate that target recruitment goals were being met.

• Design and implement protocol from bench to bedside
• Prepare submissions for FDA clearance, approvals, and 510k
• Design of EDC database and prepare reports for data safety monitoring
• Create relationships with sites for monitoring
• Handoff of approvals to regulatory and marketing
• Spearheaded full-scope clinical trial operations spanning the life cycle of product development
• Performed site and vendor feasibility
• Developed data capture database, and train site staff on protocol conduct and data capture compliance.
• Fostered positive vendor relationships to establish an efficient and reliable supply chain
• Supervised three trials across 10+ sites, with occasional onsite 2nd level monitoring as needed.
• Generated trial reports for data analysis and Data Safety Monitoring Board.

• Led research activity for sites, with critical accountability for establishing policies to ensure stringent compliance with FDA, GCP, and ICH requirements
• Responsible for data management, budgeting, contracts, resource management, and regulatory documentation for multiple clinical trials in the area of wound care and podiatric medicine.

Develop all required essential regulatory documents for assigned studies.
• Coordinate and support the development of regulatory document packages and distribution activities
to meet project timelines.
• Manage all aspects of the creation, distribution, and finalization of essential regulatory documents for
assigned projects in accordance with the protocols, ICH-GCP/ISO14155, and all applicable local laws,
regulations, company policies, and quality standards.
• Create and maintain regulatory document files for assigned Investigator sites

• Responsible for the didactic and clinical education of 1st and 2nd year Respiratory Care Students.
• Created lecture and laboratory simulation lessons.
• Oversaw student's preceptors.

• Developed course content and lecture plans for the following courses: Physiology, Medical Physics, Respiratory Pharmacology, Polysomnography, Hemodynamics, and Critical Care Medicine II.

• Led academic and industry-sponsored clinical trials for hospitals and external satellite clinics while ensuring seamless and timely communication among all research locations within the hospital’s network to drive successful program development and outcomes
• Oversaw several department’s study activities through the hospital and handled IRB reviews and submissions
• 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
• Contracted by Boehringer-Ingelheim, through Norwalk Hospital to oversee CRO activity in-house at BI as a 3rd party internal auditor.

• Conducted internal review of incoming data from CRO.

• Monitored patient's physiological responses to therapy such as ventilator settings, arterial blood gases and pulmonary function test..
• Preformed intubations, arterial line placement, hyperbaric treatment, and exercise studies.

Review assigned applications, as well as contribute to the evaluation of a research project on its scientific merits and standards of practice. Assess if a research project adequately protects the rights and welfare of subjects.