Job Description
Join our cutting-edge medical research team at MediCure Innovations, where innovation meets compassion. We're seeking a Senior Clinical Research Coordinator to drive pivotal studies that transform patient outcomes. Our state-of-the-art facility in Boston's Medical District offers unparalleled collaboration opportunities with top-tier physicians and researchers. Enjoy competitive benefits, flexible scheduling, and a culture that celebrates scientific breakthroughs. If you're passionate about accelerating medical advancements while maintaining rigorous ethical standards, this is your calling.
Responsibilities
- Design and execute clinical trial protocols in compliance with FDA regulations and GCP standards
- Manage recruitment strategies to achieve diverse patient enrollment targets
- Oversee data collection, analysis, and reporting using REDCap and CTMS systems
- Coordinate multidisciplinary teams including physicians, statisticians, and regulatory specialists
- Ensure IRB protocol adherence and maintain comprehensive regulatory documentation
- Present findings at industry conferences and peer-reviewed publications
- Mentor junior staff and optimize clinical trial workflows
Qualifications
- Master's degree in Clinical Research, Nursing, or Life Sciences (PhD preferred)
- 5+ years of clinical trial coordination experience in oncology or immunology
- Certified Clinical Research Professional (CCRP) certification required
- Advanced proficiency in electronic data capture systems and biostatistical software
- Demonstrated success in managing Phase II-III trials with 200+ participants
- Expert knowledge of 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional communication skills with ability to translate complex data
- Experience with FDA audits and regulatory submissions