Job Description
Join our pioneering team at Boston Medical Innovations, where cutting-edge research meets compassionate patient care. We're seeking a Clinical Research Coordinator to drive impactful studies in oncology and rare diseases. This role offers unparalleled opportunities to contribute to breakthrough medical advancements while working in a collaborative, state-of-the-art environment.
Our ideal candidate thrives in fast-paced clinical settings, possesses meticulous attention to detail, and is passionate about transforming healthcare through rigorous research. You'll work alongside world-renowned physicians and contribute to protocols that shape the future of medicine.
Responsibilities
- Oversee clinical trial protocols from initiation to completion, ensuring compliance with FDA and ICH-GCP standards
- Coordinate patient recruitment, enrollment, and retention strategies for diverse study populations
- Manage complex data collection, documentation, and quality assurance processes
- Collaborate with multidisciplinary teams including physicians, nurses, and regulatory affairs specialists
- Prepare and submit regulatory documents, ethics committee submissions, and study reports
- Monitor adverse events and ensure timely reporting per protocol requirements
- Maintain accurate electronic lab notebooks and study documentation
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 3+ years of clinical research coordination experience in hospital or pharmaceutical setting
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proficiency with EDC systems (e.g., Medidata Rave) and regulatory databases
- Expertise in FDA 21 CFR Part 11 compliance and ICH-GCP guidelines
- Exceptional organizational skills with ability to manage multiple concurrent protocols
- Strong written and verbal communication skills for stakeholder interactions
- Experience with oncology or rare disease trials highly desirable