Job Description
Join Boston Medical Innovations, a leader in cutting-edge medical research, as we pioneer breakthrough treatments in oncology and immunology. We seek a passionate Clinical Research Coordinator to drive our clinical trials from protocol development to FDA submission. Collaborate with multidisciplinary teams, ensure regulatory compliance, and directly impact patient outcomes while advancing medical science.
Responsibilities
- Design, implement, and monitor clinical trial protocols in compliance with FDA, GCP, and ICH guidelines
- Recruit, screen, and enroll eligible participants while maintaining accurate electronic health records
- Coordinate investigator meetings, site visits, and audit preparations
- Analyze trial data, prepare regulatory submissions, and manage adverse event reporting
- Maintain IRB approvals and ensure ethical conduct throughout trial phases
- Liaise with sponsors, CROs, and regulatory agencies for seamless trial execution
Qualifications
- Bachelor's degree in Nursing, Life Sciences, or related field (Master's preferred)
- 3+ years clinical research coordination experience in oncology/immunology trials
- Certified Clinical Research Professional (CCRP) or SOCRA certification
- Expertise in electronic data capture systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of FDA 21 CFR Part 11 and ICH-GCP regulations
- Exceptional organizational skills with meticulous attention to detail
- Excellent written/verbal communication for stakeholder management