Job Description
Join Boston Medical Center's prestigious research division as a Senior Clinical Research Coordinator and drive groundbreaking medical innovations. We're seeking a passionate professional to lead complex clinical trials, ensuring regulatory compliance while advancing patient-centered care. Collaborate with world-class physicians, researchers, and pharmaceutical partners to transform healthcare outcomes.
As part of our multidisciplinary team, you'll contribute to cutting-edge studies in oncology, cardiology, and rare diseases. Enjoy competitive benefits, flexible scheduling, and opportunities for professional development in one of America's top healthcare institutions.
Responsibilities
- Oversee end-to-end management of Phase II-III clinical trials, including protocol development, site initiation, and regulatory submissions
- Coordinate recruitment strategies to achieve diverse patient enrollment targets while maintaining strict ethical standards
- Implement and maintain robust data management systems ensuring 100% audit compliance with FDA and ICH-GCP guidelines
- Lead investigator meetings and prepare comprehensive study reports for FDA submissions and peer-reviewed publications
- Mentor junior staff and conduct internal training on clinical research best practices and regulatory updates
- Collaborate with biostatisticians to design CRFs and analyze complex clinical datasets
- Manage investigational product inventory and ensure proper disposition per protocol requirements
Qualifications
- Master's degree in Clinical Research, Public Health, or related field with 5+ years of clinical trial coordination experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Demonstrated expertise in oncology or cardiology trial management with FDA audit experience
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Oracle RDC) and CTMS platforms
- Strong knowledge of ICH-GCP, 21 CFR Part 312, and international regulatory frameworks
- Exceptional project management skills with proven ability to manage multi-center studies
- Excellent written/verbal communication skills with publication-quality report writing experience