Job Description
Join our cutting-edge research team at Boston Medical Innovations, where we pioneer breakthrough treatments in oncology and rare diseases. As a Clinical Research Coordinator, you'll drive critical trials that transform patient outcomes. We offer competitive benefits, flexible work arrangements, and opportunities for professional growth in a collaborative environment.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials per FDA/ICH guidelines
- Recruit participants and maintain compliance with HIPAA/GCP regulations
- Analyze trial data using SAS/SPSS and generate regulatory documentation
- Collaborate with biostatisticians to develop study protocols and CRFs
- Manage investigational product inventory and site audits
- Present findings at international conferences and publish in peer-reviewed journals
Qualifications
- Master's degree in Clinical Research, Nursing, or related field (PhD preferred)
- 3+ years of experience in clinical trial coordination with oncology focus
- Certification as ACRP or SOCRA certified professional
- Expertise in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of 21 CFR Part 11 and ICH-GCP standards
- Proven track record in managing multi-site international trials
- Exceptional data management and regulatory writing skills