Job Description
Join Boston Medical Innovations as a Clinical Research Coordinator and drive breakthroughs in patient care. We're seeking a passionate professional to oversee clinical trials from protocol design to FDA submission. Work with world-class researchers in our state-of-the-art facility while advancing life-changing therapies. Enjoy competitive benefits, professional development opportunities, and a collaborative environment that values innovation and patient impact.
Responsibilities
- Manage clinical trial protocols ensuring FDA/GCP compliance and regulatory documentation
- Recruit, screen, and enroll participants while maintaining ethical standards
- Coordinate multi-disciplinary teams including physicians, statisticians, and data managers
- Analyze and interpret clinical data using SAS/SPSS for reporting and publications
- Develop patient education materials and informed consent documents
- Monitor adverse events and ensure safety protocols are followed
- Liaise with IRB and regulatory bodies for protocol amendments
Qualifications
- Master's degree in Clinical Research, Nursing, Life Sciences, or related field
- 3+ years clinical trial coordination experience in oncology or cardiology
- Certified Clinical Research Professional (CCRP) certification preferred
- Proficiency in EDC systems (e.g., Medidata Rave) and regulatory databases
- Strong statistical knowledge with experience in SAS programming
- Excellent communication skills for stakeholder collaboration
- Ability to manage complex timelines and competing priorities
- Knowledge of 21 CFR Part 11 and ICH-GCP guidelines