Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we pioneer breakthrough treatments in oncology and rare diseases. We're seeking a Senior Clinical Research Coordinator to drive our mission of transforming patient care through rigorous scientific excellence. In this pivotal role, you'll orchestrate complex clinical trials, collaborate with multidisciplinary teams, and ensure compliance with FDA and ICH-GCP standards. Our state-of-the-art facilities in Boston's Longwood Medical Area offer an unparalleled environment for professional growth and impactful work.
Responsibilities
- Design and implement comprehensive clinical trial protocols with meticulous attention to regulatory requirements
- Manage site initiation, monitoring, and closure activities across multiple research sites
- Oversee data integrity through source verification, CRF completion, and EDC management
- Liaise with ethics committees, sponsors, and regulatory bodies to ensure protocol compliance
- Mentor junior coordinators and train staff on clinical research best practices
- Analyze trial data and prepare comprehensive reports for FDA submissions and internal stakeholders
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- 5+ years of experience in oncology or rare disease clinical trials
- Expertise in FDA 21 CFR Part 56, ICH-GCP, and ISO 14155 standards
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave)
- Proven track record in managing multi-site trials with complex protocols
- Exceptional problem-solving skills and attention to regulatory documentation