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Ashley Perosi

@ashleyperosi

Detail-oriented clinical research professional specializing in study start-up, regulatory submissions, and site activation.

United States

Message

What I'm looking for

I am seeking a clinical operations or study start-up role where I can lead regulatory submissions, optimize start-up timelines, mentor teams, and drive compliant, efficient site activations.

I am a clinical research professional with 8+ years of hands-on experience managing study start-up activities, regulatory submissions, and site activation for global clinical trials. I ensure compliance with ICH-GCP, SOPs, and local regulations while maintaining audit-ready documentation.

Throughout my career I have led execution of start-up projects, prepared IRB/EC submissions, tracked milestones and site activation timelines, and supported contract and budget negotiations. I have mentored junior staff, coordinated cross-functional teams, and implemented process improvements to optimize timelines and operational efficiency.

I am proficient with CTMS and document management systems and bring strong stakeholder communication, risk management, and timeline management skills. I focus on delivering reliable, compliant start-up processes that support successful trial initiation and enrollment.

Experience

Work history, roles, and key accomplishments

Associate Project Manager I

Fortrea

Sep 2022 - Jul 2025 (2 years 10 months)

Led execution of multiple study start-up projects, managing timelines, documentation, and stakeholder communication to achieve site activation and enrollment targets; prepared IRB/EC submissions and maintained audit-ready eTMF and CTMS records.

Study Start Up IRB Submission ETMF Regulatory Compliance

Sr. Start-Up Specialist

Labcorp

Oct 2021 - Sep 2022 (11 months)

Oversaw regulatory document collection and quality review for site activation, managed IRB submissions and contract negotiations, and mentored junior staff to meet project objectives and timelines.

Regulatory IRB Submission Contract Negotiation CTMS ETMF Mentorship Cross Functional Collaboration Quality

Start-Up Specialist

Labcorp

Jun 2018 - Sep 2021 (3 years 3 months)

Coordinated essential document collection and regulatory authority submissions across multiple studies, supported compliance tracking and project reporting to meet site activation milestones.

Essential Document Collection Regulatory Submissions Compliance Reporting CTMS ETMF Project Reporting

Start-Up Associate

Covance

Oct 2016 - May 2018 (1 year 7 months)

Organized and tracked regulatory documentation for site activation and maintained document management systems to support audit readiness and protocol compliance.

Regulatory ETMF Document Management Site Activation Management