REQUIRED SKILLS AND EXPERIENCE
7+ years of experience in clinical research focused on class III devices
Experience with site management
Experience with Medidata Rave EDC and VEVA ETMF
Project management experience - finances, accruals, invoices from vendors
Bachelor's Degre
JOB DESCRIPTION
A medical device company located in Irvine, CA is looking for a Sr. Clinical Research Specialist to play a critical role in the design, execution, and management of clinical research studies.
The responsibilities include but are not limited to :
- Study Design and Planning : Develop and design clinical research protocols, ensuring alignment with regulatory requirements and company objectives.
- Project Management : Oversee the execution of clinical trials, including site selection, patient recruitment, data collection, and monitoring.
- Regulatory Compliance : Ensure all clinical research activities comply with FDA regulations, ICH-GCP guidelines, and other relevant regulatory standards.
- Data Analysis and Reporting : Analyze clinical trial data and prepare comprehensive reports for internal and external stakeholders.
- Vendor Management : Manage relationships with clinical sites and other external partners to ensure high-quality and timely execution of clinical studies.
- Risk Management : Identify and mitigate potential risks associated with clinical trials to ensure patient safety and data integrity.
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