Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we pioneer breakthrough treatments for rare diseases. We're seeking a passionate Senior Clinical Research Coordinator to oversee multi-center trials while maintaining compliance with FDA and ICH-GCP standards. This hybrid role combines impactful patient engagement with sophisticated data management in our state-of-the-art Boston facility.
Why Join Us?
- Competitive compensation with comprehensive benefits package
- Professional development funding for certifications (SOCRA, ACRP)
- Collaborative environment with 40% women leadership
- Clinical trial access before public availability
Responsibilities
- Manage 5-6 Phase II/III clinical trials across 15+ research sites
- Oversee patient recruitment strategies achieving 92% enrollment targets
- Ensure regulatory compliance through protocol amendments and FDA submissions
- Train 15+ junior coordinators in GCP and electronic data capture systems
- Analyze adverse event reports using MedDRA terminology
- Collaborate with biostatisticians on interim analysis for safety endpoints
- Present trial progress to Data Safety Monitoring Board quarterly
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years coordinating oncology/neurology trials with complex protocols
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- Expertise in Oracle RDC and ClinCapture EDC systems
- Proven experience managing multi-site audits with 0 major findings
- Strong understanding of 21 CFR Part 11 compliance requirements
- Experience with rare disease patient advocacy groups