Job Description
Join our pioneering team at MedTech Innovations Group, where cutting-edge medical research meets compassionate patient care. We're seeking a meticulous Clinical Research Associate to drive transformative clinical trials that shape the future of healthcare. Collaborate with world-class physicians, pharmaceutical partners, and regulatory experts in a dynamic environment dedicated to scientific excellence and patient safety. Enjoy competitive compensation, comprehensive benefits, and opportunities to advance your career in one of America's premier biotech hubs.
Responsibilities
- Design, implement, and monitor clinical trial protocols ensuring compliance with FDA regulations and GCP standards
- Coordinate site initiation, interim monitoring, and close-out visits across 5-10 research sites
- Manage electronic data capture systems and ensure accurate documentation of adverse events
- Collaborate with biostatisticians to analyze trial data and prepare regulatory submissions
- Maintain relationships with investigators, sponsors, and ethics committees
- Lead training sessions for site staff on protocol procedures and compliance requirements
- Prepare comprehensive study reports and regulatory documentation for FDA submissions
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 3+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle Clinical)
- Deep knowledge of ICH-GCP, FDA 21 CFR Part 312, and EU clinical trial regulations
- Exceptional attention to detail and documentation accuracy
- Strong project management skills with ability to handle multiple sites
- Excellent communication skills for cross-functional collaboration