Job Description
Join Boston's premier biomedical research institute at the forefront of groundbreaking medical discoveries. We seek a passionate Clinical Research Coordinator to drive our oncology trials from protocol to publication. This hybrid role blends lab precision with patient advocacy in our state-of-the-art facilities near Longwood Medical Area.
Our team operates at the intersection of innovation and compassion, where your expertise directly impacts patient outcomes. Enjoy competitive benefits, flexible scheduling, and continuous learning opportunities in a culture that values scientific rigor and human connection.
Responsibilities
- Design, implement, and monitor Phase I-III oncology clinical trials per FDA and ICH-GCP standards
- Coordinate patient recruitment, screening, and retention across 3+ clinical sites
- Manage electronic data capture (EDC) systems and ensure regulatory documentation compliance
- Liaise between investigators, sponsors, and ethics committees for protocol amendments
- Analyze interim data and prepare comprehensive safety reports for regulatory submissions
- Mentor junior staff on clinical trial methodologies and regulatory requirements
Qualifications
- Master's degree in Clinical Research, Nursing, or related life sciences field
- 3+ years' experience in oncology clinical trials with 2+ years in coordinator role
- Certified Clinical Research Professional (CCRP) or ACRP-CC certification
- Proficiency in Medidata Rave and Oracle Clinical systems
- Demonstrated expertise in IRB submissions and FDA Form 1572 documentation
- Exceptional interpersonal skills for patient-centered communication
- Proven track record in protocol development and site initiation