Job Description
Join MediCure Innovations' cutting-edge clinical research division as we pioneer next-generation treatments for rare diseases. We're seeking a meticulous Senior Clinical Research Coordinator to orchestrate multi-center trials from protocol design to FDA submission. You'll collaborate with world-class physicians, biostatisticians, and regulatory experts in our state-of-the-art Boston facility. Enjoy comprehensive benefits including tuition reimbursement, flexible scheduling, and equity participation in our portfolio of patented therapies.
Responsibilities
- Design and execute complex clinical trial protocols adhering to ICH-GCP guidelines
- Manage investigator relationships at 5+ participating medical centers
- Analyze adverse event reports and ensure regulatory compliance
- Prepare FDA submissions and maintain audit-ready documentation
- Mentor junior CRCs and optimize trial workflows
- Present findings at international conferences and peer-reviewed journals
- Coordinate with biostatistics team for interim analysis and endpoint validation
Qualifications
- Master's degree in Clinical Research, Nursing, or related field (PhD preferred)
- 5+ years of experience in clinical trial coordination with rare disease focus
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in electronic data capture systems (e.g., Medidata Rave)
- Proven success in FDA 1572 and IND applications
- Strong knowledge of 21 CFR Part 11 and HIPAA regulations
- Experience with multi-center trials across 3+ states
- Exceptional data management and audit trail documentation skills