Senior Clinical Research Coordinator
5 days ago
We are seeking a highly skilled Clinical Research Specialist to play a critical role in the design, execution, and management of clinical research studies. The ideal candidate will have a strong background in clinical research, excellent project management skills, and the ability to work effectively in a fast-paced environment.
Key Responsibilities- 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.
- 7+ years of experience in clinical research focused on medical device or pharmaceutical
- Experience with site management
- Experience with EDC and ETMF
- Project management experience - finances, accruals, invoices from vendors
- Bachelor's Degree
$110,000 - $145,000
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