Job Description
Join MedTech Innovations at the forefront of medical breakthroughs as a Senior Clinical Research Coordinator. You'll orchestrate complex clinical trials, ensuring compliance with FDA regulations while driving life-saving innovations. Our collaborative environment empowers you to shape the future of patient care through rigorous research methodologies and cutting-edge technology.
Responsibilities
- Design and implement comprehensive clinical trial protocols in compliance with GCP standards
- Manage site relationships with 10+ partner hospitals across New England
- Analyze and interpret complex medical data using SAS and R programming
- Coordinate IRB submissions and regulatory documentation
- Mentor junior CRCs and oversee study budgets
- Present findings to FDA panels and industry stakeholders
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years of clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) certification
- Expertise in oncology or rare disease trials preferred
- Advanced proficiency in EDC systems (Medidata Rave)
- Strong data visualization and statistical analysis skills
- Proven track record of FDA audit readiness