Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we pioneer breakthrough treatments in oncology and rare diseases. We seek a meticulous Clinical Research Coordinator to drive our mission of transforming patient care through rigorous, compassionate science. This hybrid role offers the opportunity to work with world-class physicians while making tangible impact in healthcare innovation. Our collaborative environment fosters professional growth through continuous learning and mentorship from industry veterans.
Responsibilities
- Oversee end-to-end clinical trial execution including protocol development, site activation, and patient recruitment
- Ensure strict compliance with FDA regulations, GCP standards, and institutional review board protocols
- Manage complex data collection, verification, and submission using EDC systems like Medidata Rave
- Coordinate multidisciplinary teams including investigators, sponsors, and regulatory affairs specialists
- Monitor adverse events and safety reporting with real-time vigilance
- Conduct site visits and audits to maintain data integrity and operational excellence
- Maintain comprehensive regulatory documentation and trial master files
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- Minimum 3 years clinical research coordination experience with oncology trials
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- Expertise in EDC platforms (Medidata, Oracle) and regulatory databases
- Proven success in meeting enrollment targets and maintaining trial timelines
- Exceptional attention to detail with documented audit compliance history
- Strong analytical skills for protocol design and risk assessment
- Ability to navigate complex regulatory environments in academic and hospital settings