Danielle O.

Danielle O.

Quality Control Equipment Specialist @ Moderna

About

I hold a Bachelor of Science in Biology with experience in quality control, laboratory testing, and regulatory compliance within the pharmaceutical and biotechnology industries. Through my hands-on work in GMP-regulated environments, I have developed a strong foundation in scientific analysis, data integrity, and compliance—key elements that drive high-quality clinical research. My interest in clinical research stems from a desire to be directly involved in advancing medical treatments that improve patient outcomes. I am particularly drawn to the impact of clinical trials in bridging the gap between scientific discovery and real-world application. The idea of working on studies that help bring life-changing therapies to market excites me, and I am eager to apply my analytical mindset, attention to detail, and problem-solving skills to this field. I am currently looking to transition into clinical research roles such as, Clinical Trial Associate (CTA), Clinical Research Assistant (CRA), Compliance Specialist and Regulatory Affairs Specialist to gain hands-on experience in clinical trial operations, regulatory guidelines, and patient-centered research. I am actively seeking opportunities to expand my knowledge in Good Clinical Practice (GCP), trial monitoring, protocol adherence, and data management. Beyond my professional aspirations, I value collaboration and continuous learning. I am always open to networking with professionals in the clinical research community—whether it’s to exchange insights, learn from experienced researchers, or explore career opportunities. If you’re in the field of clinical research, pharmaceuticals, or biotechnology, I would love to connect and discuss potential collaborations or internship opportunities. Feel free to reach out—I look forward to connecting and growing in this exciting and meaningful industry!

Country

United States

City

Worcester

Industry

Biotechnology

Skill

ICH E6 (R2) GCP , Clinical Trial Management System (CTMS), Clinical Monitoring , Electronic Data Capture (EDC), ICH-GCP guidelines , RECIST, CTCAE criteria, Clinical Research, Clinical Trials, Project Management, Ethics, Regulatory Affairs, Quality Assurance, Documentation, Participant Safety & Adverse Events, Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Batch Records, Scientific Papers, Microsoft Office

Experience

Moderna

Quality Control Equipment Specialist

Moderna

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2025-3 - Present · 1 yr 7 mos
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Remote Clinical Research Associate - Bridge Program

ALLEN SPOLDEN

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2025-7 - 2025-8 · 2 mos
Obedtek

Clinical Research Associate Program

Obedtek

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2025-5 - 2025-7 · 3 mos
Labcorp

Laboratory Assistant IV

Labcorp

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2025-1 - 2025-3 · 3 mos
Bristol Myers Squibb

Quality Control Equipment Specialist

Bristol Myers Squibb

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2022-7 - 2023-8 · 1 yr 2 mos
Insulet Corporation

Manufacturing Quality Specialist

Insulet Corporation

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2019-10 - 2022-7 · 2 yrs 10 mos
CVS Pharmacy

Shift Supervisor

CVS Pharmacy

LinkedIn
2018-6 - 2019-10 · 1 yr 5 mos

Massachusetts, United States

Education

Worcester State University

Worcester State University

LinkedIn

Biology, General

Danielle O.'s Contact Information

Email

******@***.com

Phone

(**) *** ****

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