Job Description
Join MedTech Innovations at the forefront of medical breakthroughs as our Senior Clinical Research Coordinator. You'll orchestrate groundbreaking clinical trials, ensuring compliance with FDA regulations while driving innovation in patient care. Our Boston-based team operates at the intersection of technology and healthcare, offering unparalleled opportunities to shape the future of medicine. We provide comprehensive benefits, competitive compensation, and a collaborative environment where your expertise directly impacts human health.
Responsibilities
- Design and implement clinical trial protocols in compliance with FDA, ICH-GCP, and institutional guidelines
- Manage site activation, recruitment, and patient enrollment strategies for multi-center trials
- Oversee data collection, quality assurance, and regulatory documentation processes
- Coordinate cross-functional teams including physicians, biostatisticians, and regulatory affairs specialists
- Analyze clinical trial data and prepare comprehensive reports for FDA submissions
- Maintain electronic data capture systems and ensure data integrity throughout trials
- Represent the company at investigator meetings and regulatory agency consultations
Qualifications
- Master's degree in Clinical Research, Nursing, Public Health, or related field
- 5+ years of clinical trial coordination experience in pharmaceutical or medical device setting
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in clinical trial management systems (e.g., Medidata Rave, Oracle Inform)
- Demonstrated expertise in FDA 21 CFR Part 11 compliance and risk-based monitoring
- Strong knowledge of ICH-GCP, FDA regulations, and international clinical trial standards
- Exceptional project management skills with ability to manage complex multi-center trials
- Excellent written and verbal communication skills for regulatory documentation and stakeholder engagement