Job Description
Join Boston Medical Center's prestigious research division as a Senior Clinical Research Coordinator and lead groundbreaking studies in oncology and immunotherapy. We're seeking a passionate professional to ensure compliance with FDA regulations, manage complex trial protocols, and collaborate with multidisciplinary teams to advance patient care. Our state-of-the-art facilities and NIH-funded research offer unparalleled opportunities for professional growth in one of America's top healthcare systems.
Responsibilities
- Oversee end-to-end clinical trial execution from protocol design to FDA submission
- Coordinate with principal investigators to ensure protocol adherence and data integrity
- Manage IRB submissions and maintain regulatory compliance documentation
- Train and mentor junior research staff on SOPs and GCP standards
- Analyze trial data using SAS and generate comprehensive study reports
- Liaise with pharmaceutical sponsors and CROs on trial progress and deliverables
- Implement risk-based monitoring strategies for trial sites
Qualifications
- Master's degree in Clinical Research, Public Health, or related field
- 5+ years of clinical research coordination experience in oncology trials
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- Expertise in FDA regulations, ICH-GCP, and 21 CFR Part 8 compliance
- Advanced proficiency in REDCap, Medidata Rave, and SAS programming
- Proven track record of managing multi-center phase II/III trials
- Strong leadership skills with experience mentoring research teams
- Excellent written communication for regulatory documentation