Job Description
Join our pioneering team at MedTech Innovations Group, where we're transforming patient care through cutting-edge clinical trials. We seek a Senior Clinical Research Coordinator to oversee complex oncology studies, ensuring regulatory compliance and data integrity while mentoring junior staff. Collaborate with leading physicians and pharmaceutical partners to accelerate life-saving therapies to market. Enjoy competitive benefits, flexible scheduling, and opportunities for professional growth in Boston's vibrant healthcare ecosystem.
Responsibilities
- Design and implement clinical trial protocols for Phase II-III oncology studies
- Monitor site compliance with FDA regulations, GCP standards, and IRB requirements
- Manage electronic data capture systems and ensure 99.5% data accuracy
- Train and mentor 3-5 junior research coordinators on best practices
- Coordinate investigator meetings and prepare FDA submissions
- Analyze adverse event reports and safety data for regulatory reporting
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- 5+ years' experience in oncology clinical trials with Phase II-III studies
- Expertise in EDC systems (Medidata Rave, Veeva Vault)
- Proven track record in FDA submissions and audit readiness
- Strong leadership experience with cross-functional teams
- Knowledge of 21 CFR Part 11 and ICH-GCP guidelines