Job Description
Join our pioneering clinical research team at MediTech Innovations, where cutting-edge medical solutions meet compassionate patient care. We're seeking a Senior Clinical Research Coordinator to lead complex oncology trials at our Boston headquarters. Enjoy comprehensive benefits including 401(k) matching, tuition reimbursement, and flexible work arrangements in a state-of-the-art facility.
Responsibilities
- Design and implement Phase II-III oncology clinical trials in compliance with FDA regulations
- Oversee site management activities including budgeting, contract negotiations, and vendor coordination
- Maintain accurate electronic data capture systems and regulatory documentation
- Lead cross-functional teams including biostatisticians, physicians, and regulatory affairs specialists
- Develop patient recruitment strategies and ensure protocol adherence across multiple sites
- Prepare FDA submissions and manage audit inspections
Qualifications
- Master's degree in Clinical Research, Nursing, or related field with 5+ years' experience
- Certified Clinical Research Professional (CCRP) certification required
- Proven expertise in oncology trial management and GCP compliance
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave)
- Strong project management skills with PMP certification preferred
- Experience with FDA audits and regulatory submissions
- Excellent written communication for protocol development and reporting