Open to opportunities

Sheila Nardelli

@sheilanardelli

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Dedicated clinical trial associate with over 15 years of experience.

United States

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What I'm looking for

I am looking for a role that values integrity and offers opportunities for professional growth in clinical research.

I am an organized and hardworking professional with over 15 years of experience in managing pharmaceutical and device studies, specifically in ophthalmology. My career has been dedicated to ensuring compliance with regulatory requirements and maintaining high standards in patient care at both the site and CRO levels. I have a proven track record of leading teams to meet study goals while upholding integrity and quality in clinical trials.

Throughout my career, I have successfully managed FDA clinical trials from pre-study phases through to completion, overseeing everything from budgets and contracts to recruitment and data collection. My experience includes working with various sponsors and CROs, and I have developed a reputation for being detail-oriented and efficient in my work. I am proficient in document management and study logistics, ensuring that all aspects of clinical trials are executed smoothly and effectively.

Experience

Work history, roles, and key accomplishments

Clinical Trial Associate

Sierra Clinical Services, LLC

Nov 2024 - Jul 2025 (8 months)

Supported clinical studies and project managers by handling essential document management, study logistics, and site coordination. Maintained study eTMFs, performed document uploads, and quality checks.

ETMF Document Control Regulatory Submissions Google Workspace Adobe Excel Word

Clinical Research Study Coordinator

Hill Country Eye Center

Jun 2016 - Nov 2024 (8 years 5 months)

Managed FDA clinical trials from pre-study through completion, ensuring compliance with protocol requirements. Led the study team to meet project goals, timelines, and expectations.

Clinical Trial Management FDA GCP Patient Recruitment Data Collection SOP Development

Content Moderator

Bazaarvoice

Apr 2017 - Nov 2019 (2 years 7 months)

Reviewed and applied codes to large quantities of customer reviews and content, ensuring compliance with client guidelines. Achieved company goals for content analysis per minute.

Content Moderation Quality Assurance Client Guidelines Time Management Remote Work

Lead Ophthalmic Technician/Study Coordinator

Feinerman Vision Center

Jul 2004 - Jun 2016 (11 years 11 months)

Performed patient workups and care, including ophthalmology assessments and special diagnostic testing. Managed FDA clinical trials from startup to completion, including patient recruitment and data collection.

Ophthalmology Patient Care Clinical Trial Management FDA Patient Recruitment Data Collection Regulatory Compliance Surgical Assisting

Education

Degrees, certifications, and relevant coursework

Emory University

Master of Medical Science, Ophthalmic Technology

Received ophthalmology clinical training and necessary for taking the JCAHPO COMT certification exams. Obtained the research experience and training required for completing a Research Thesis Project.