Senior Clinical Trial Associate
New
J
JobgetherClinical Operations
Based in United StatesFull-TimeSenior
Salary$85,000–$115,000
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Job Details
- Experience
- At least 3 years of clinical trial experience
- Required Skills
- Microsoft Excel
Requirements
- Bachelor’s degree in a health profession, life science, or related scientific discipline.
- Minimum 3 years of clinical trial experience with involvement in ongoing studies.
- Solid understanding of Good Clinical Practice (GCP) principles.
- Knowledge of FDA regulatory requirements.
- Familiarity with medical terminology and clinical research processes.
- Proficiency in Microsoft Word, Excel, and Outlook.
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills.
- Ability to work independently and exercise sound judgment in a regulated environment.
- Willingness to travel occasionally as required.
Responsibilities
- Support clinical trial managers with activities including clinical planning, protocol development, IRB submissions, and Trial Master File preparation.
- Coordinate with clinical trial sites regarding administrative documentation, study materials, and site start-up requirements.
- Maintain compliance with FDA regulations, Good Clinical Practice, and internal standard operating procedures.
- Assist with communication regarding study conduct, monitoring activities, and closeout activities.
- Track study-related payments, invoices, and financial or administrative documentation.
- Contribute to projects of moderate to high complexity across R&D, Regulatory, Safety, and Quality teams.
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