Job Description
Join MedTech Innovations as a Clinical Research Coordinator and become a pivotal force in advancing medical breakthroughs. We're seeking a dedicated professional to orchestrate complex clinical trials, ensuring compliance with FDA regulations and GCP standards. Our state-of-the-art facilities in Boston's medical district provide an environment where innovation meets patient-centered care. Collaborate with cross-functional teams to transform scientific discoveries into life-changing therapies while maintaining the highest ethical standards.
Responsibilities
- Design and execute clinical trial protocols with meticulous attention to detail
- Monitor site compliance through regular audits and source document verification
- Coordinate patient recruitment and informed consent processes
- Manage electronic data capture systems and ensure data integrity
- Prepare regulatory submissions and maintain comprehensive trial documentation
- Facilitate communication between investigators, sponsors, and ethics committees
- Analyze adverse events and safety reports per regulatory requirements
Qualifications
- Master's degree in Clinical Research, Nursing, or related health field
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Minimum 3 years of clinical trial coordination experience
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle Clinical)
- Deep knowledge of FDA 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional organizational skills with ability to manage multiple timelines
- Strong written/verbal communication skills for stakeholder interactions