Job Description
Join Boston Medical Center's cutting-edge research division and play a pivotal role in advancing medical breakthroughs. We seek a meticulous Clinical Research Coordinator to oversee complex clinical trials, ensuring compliance with FDA regulations and institutional protocols. You'll collaborate with multidisciplinary teams to drive patient-centric studies that transform healthcare outcomes. This hybrid role offers competitive benefits, professional development opportunities, and the chance to contribute to life-changing innovations.
Responsibilities
- Manage all aspects of clinical trials including protocol implementation, patient recruitment, and data collection
- Maintain meticulous documentation of trial activities in compliance with FDA 21 CFR Part 11 and ICH-GCP
- Coordinate with principal investigators, sponsors, and regulatory bodies to ensure protocol adherence
- Monitor adverse events and ensure timely reporting to IRB and ethics committees
- Analyze clinical data and prepare comprehensive reports for stakeholders
- Train site staff on research protocols and regulatory requirements
- Leverage REDCap and EDC systems for efficient data management
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Minimum 3 years experience in clinical trial coordination
- Expertise in FDA regulations, ICH-GCP, and 21 CFR Part 11 compliance
- Proficiency in electronic data capture systems (REDCap, Medidata Rave)
- Exceptional organizational skills with attention to detail
- Strong written communication for reporting and documentation
- Ability to manage multiple complex projects simultaneously