Job Description
Join our pioneering team at MediCore Innovations, where we're transforming healthcare through groundbreaking clinical research. We're seeking a passionate Senior Clinical Research Coordinator to lead pivotal studies in our state-of-the-art Boston facility. Be at the forefront of medical innovation while making a tangible impact on patient care.
What You'll Love About Us:
- Collaborative environment with world-renowned physicians and researchers
- Cutting-edge facilities and access to latest medical technologies
- Comprehensive professional development and continuing education
- Competitive benefits package including health, dental, and retirement plans
Responsibilities
- Design, implement, and oversee complex clinical trial protocols in compliance with FDA/ICH-GCP regulations
- Manage site operations, budgets, and timelines for multi-center studies
- Recruit, screen, and retain diverse patient populations for critical research cohorts
- Analyze clinical data and prepare comprehensive regulatory submissions
- Lead cross-functional teams including physicians, biostatisticians, and ethics committees
- Develop patient education materials and ensure ethical consent processes
- Monitor adverse events and ensure protocol adherence across all study sites
Qualifications
- Master's degree in Clinical Research, Nursing, or Life Sciences with 5+ years' experience
- Certification as a Principal Investigator (PI) or Clinical Research Professional (CCRP)
- Demonstrated expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and regulatory databases
- Proven track record of leading FDA submissions and audit compliance
- Exceptional project management skills with PMP certification preferred
- Strong knowledge of HIPAA, 21 CFR Part 820, and international regulatory frameworks