Job Description
Join MedTech Innovations as a Senior Clinical Research Coordinator and lead transformative clinical trials that shape the future of healthcare. We're seeking a dedicated professional to oversee complex research protocols while ensuring regulatory compliance and data integrity. Collaborate with cross-functional teams across our state-of-the-art Boston facility to bring life-saving treatments from concept to reality. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional growth in one of America's premier healthcare hubs.
Responsibilities
- Design, implement, and monitor clinical trial protocols in compliance with FDA regulations and ICH-GCP standards
- Coordinate multi-site research activities including patient recruitment, informed consent, and data collection
- Lead cross-functional teams of physicians, nurses, and data specialists to ensure trial milestones
- Manage electronic data capture systems and maintain accurate trial documentation
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approval
- Conduct site visits and audits to ensure protocol adherence and data quality
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of clinical trial coordination experience with Phase II-III studies
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in electronic data capture systems (e.g., Medidata Rave, Oracle Inform)
- Strong understanding of FDA 21 CFR Part 11 and ICH-GCP guidelines
- Proven track record of successful FDA/EMA submissions
- Exceptional project management and stakeholder communication skills