Open to opportunities

Laura Bernal

@laurabernal

Message

Clinical research professional with strong study start-up, regulatory, and customer-service expertise.

United States

Message

What I'm looking for

I seek a clinical operations role focused on study start-up or site management where I can apply regulatory expertise, improve processes, and deliver compliant, timely activations.

I am a clinical research professional specializing in study start-up, regulatory submissions, and contract negotiation, with experience across hepatology, neurology, oncology, and internal medicine.

I bring a customer-focused mindset developed through roles in elder care consulting, financial services, and retail, consistently improving processes, meeting quality targets, and delivering high-touch service.

I am proficient with Medidata CTMS, PhlexEview eTMF and Veeva Vault eTMF, and I follow ICH/GCP and local regulatory requirements to ensure timely, compliant study activation.

Experience

Work history, roles, and key accomplishments

Current

Study Start-Up Associate

Current

ICON

Dec 2021 - Present (3 years 10 months)

Coordinated study start-up activities, managing ICFs, CTAs, budgets and regulatory submissions to ensure timely site activation and compliance with ICH/GCP; negotiated agreements and escalated issues to legal and clinical teams.

Study Start Up ICH GCP Informed Consent Forms Clinical Trial Agreements Regulatory Submissions Medidata CTMS

Senior Consultant & Care Coach

Workplace Options

Jan 2020 - Nov 2021 (1 year 10 months)

Provided elder-care consultations and care coordination, increasing referrals to community resources and consistently exceeding quality and production targets while maintaining regulatory and audit compliance.

Elder Care Consulting Care Coordination Client Relations Regulatory Compliance Customer Service Data Entry

Professional Associate

Trader Joe's

Mar 2019 - Oct 2020 (1 year 7 months)

Delivered high-quality customer service in a fast-paced retail environment, improving customer satisfaction and retention through product expertise and effective issue resolution.

Customer Service Product Knowledge Sales Support Time Management Point of Sale Conflict Resolution Upselling

Financial Associate

Fidelity Investments

Feb 2016 - Feb 2019 (3 years)

Managed over 700 inbound client calls monthly supporting 401(k) services, processed plan transactions, and ensured compliance with IRS and fiduciary regulations while using FPRS and XTRAC systems.

401(k) Administration client support Regulatory Compliance Record keeping