Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical trials, as we revolutionize patient care through groundbreaking research. We're seeking a meticulous Clinical Research Coordinator to orchestrate complex multi-center studies while ensuring regulatory compliance and data integrity. This role offers the opportunity to directly impact medical breakthroughs in oncology and rare diseases while working alongside world-renowned physicians. Our collaborative environment supports professional growth through industry conferences and advanced certifications.
Responsibilities
- Oversee all phases of clinical trials from protocol development to final report submission
- Recruit, screen, and enroll qualified participants while maintaining strict ethical standards
- Manage electronic data capture systems and ensure 100% audit-ready documentation
- Coordinate with IRB/EC submissions and maintain compliance with FDA/GCP regulations
- Liaise between investigative sites, sponsors, and regulatory bodies
- Analyze interim data and prepare study progress reports for stakeholders
- Train clinical staff on protocol requirements and SOPs
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- 3+ years of clinical research coordination experience in oncology trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Proven track record of maintaining 100% audit-ready records
- Strong knowledge of ICH-GCP and 21 CFR Part 11 regulations
- Exceptional organizational skills with attention to minute details
- Ability to manage competing priorities in fast-paced environments