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@laurabernal
Clinical research professional with strong study start-up, regulatory, and customer-service expertise.
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.
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Work history, roles, and key accomplishments
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.
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.
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.
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.
Degrees, certifications, and relevant coursework
Undergraduate, Communications
Undergraduate degree with a minor in Advocacy & Law (American History) completed in 2010.
High School Diploma, High School Education
Completed high school education at Sanderson High School in Raleigh, NC, graduating in 2006.
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