Job Description
Shape the Future of Medicine at Precision Health Institute
We're seeking a visionary Clinical Research Coordinator to drive groundbreaking medical trials in cardiovascular health. Join our NIH-funded team at Boston's premier research hub, where your expertise will directly impact patient care and medical innovation.
Why Join Us?
• Collaborate with world-class cardiologists and molecular biologists
• Access state-of-the-art facilities including our AI-driven data analysis lab
• Comprehensive benefits including tuition reimbursement and professional development grants
• Work in a dynamic environment that values intellectual curiosity and ethical rigor
Responsibilities
- Manage Phase I-III clinical trials from protocol development to final report submission
- Ensure strict FDA 21 CFR Part 820 and ICH-GCP compliance
- Coordinate multi-center studies across 5+ Boston hospitals
- Oversee electronic data capture systems and maintain regulatory documentation
- Lead investigator meetings and regulatory authority inspections
- Mentor junior research staff and train new study coordinators
- Analyze trial data using SAS and generate statistical reports for FDA submissions
Qualifications
- Master's degree in Clinical Research, Nursing, or Life Sciences (PhD preferred)
- 3+ years of clinical trial coordination in cardiovascular or oncology research
- Certified Clinical Research Professional (CCRP) certification required
- Expertise in FDA regulations, ISO 14155, and clinical risk management
- Advanced proficiency in Medidata Rave and Oracle Clinical
- Demonstrated experience managing FDA audits and site inspections
- Strong publication record in peer-reviewed medical journals