Job Description
Join Boston Medical Innovations as a Senior Clinical Research Coordinator and spearhead groundbreaking studies that transform patient care. We're seeking a meticulous professional to manage complex clinical trials from protocol design to FDA submission. Our state-of-the-art facility in Boston's medical district offers unparalleled resources and collaborative opportunities. Work alongside world-class physicians while contributing to life-changing therapies in oncology and rare diseases.
Responsibilities
- Oversee end-to-end clinical trial execution including site selection, patient recruitment, and protocol compliance
- Coordinate with regulatory bodies (FDA, IRB) to ensure adherence to GCP and 21 CFR Part 11 standards
- Manage electronic data capture systems and validate clinical data integrity
- Mentor junior coordinators and conduct investigator meetings at leading medical centers
- Prepare regulatory submissions and maintain comprehensive study documentation
- Analyze adverse event reports and safety data for pharmacovigilance
- Collaborate with biostatisticians on clinical endpoint analysis and reporting
Qualifications
- Master's degree in Clinical Research, Public Health, or related field with 5+ years of clinical trial experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in Medidata Rave and Oracle Clinical systems
- Demonstrated success in managing multi-center Phase II-III trials
- Strong knowledge of ICH-GCP guidelines and FDA regulations
- Exceptional project management skills with PMP certification preferred
- Experience with FDA audit preparation and site management