Job Description
Join our cutting-edge medical research team at Boston Medical Innovations, where we pioneer breakthrough treatments in oncology and immunotherapy. We seek a meticulous Clinical Research Coordinator to drive complex clinical trials from protocol to execution. This pivotal role ensures regulatory compliance, data integrity, and patient safety while collaborating with multidisciplinary teams. Our state-of-the-art facilities offer unparalleled resources for medical innovation.
Responsibilities
- Design, implement, and monitor clinical trial protocols adhering to FDA/ICH-GCP standards
- Recruit, screen, and enroll qualified study participants while maintaining ethical standards
- Manage electronic data capture systems ensuring 100% data accuracy and audit readiness
- Coordinate with IRB, sponsors, and investigative sites for regulatory compliance
- Prepare regulatory submissions and maintain comprehensive study documentation
- Train staff on SOPs and conduct source data verification audits
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 3+ years' experience in clinical trial coordination with FDA-regulated trials
- Certified Clinical Research Professional (CCRP) or SOCRA certification required
- Expertise in electronic data capture systems (e.g., Medidata Rave, Oracle InForm)
- Strong knowledge of 21 CFR Parts 11, 312, and ICH-GCP guidelines
- Exceptional attention to detail with proven audit success rate
- Experience with oncology/immunology trials preferred