Job Description
Join Boston Medical Innovations, a leader in cutting-edge clinical research, as we revolutionize patient care through groundbreaking trials. We're seeking a passionate Senior Clinical Research Coordinator to drive excellence in our oncology studies. You'll collaborate with multidisciplinary teams to ensure protocol compliance, patient safety, and data integrity while contributing to life-changing therapies. Enjoy competitive benefits, professional development opportunities, and the chance to make a tangible impact in healthcare.
Responsibilities
- Oversee all aspects of clinical trial execution including protocol implementation, patient recruitment, and site monitoring
- Manage electronic data capture systems (EDC) ensuring data accuracy and regulatory compliance
- Serve as primary liaison between investigators, sponsors, and regulatory bodies
- Develop and maintain comprehensive study documentation (CRFs, IBs, SOPs)
- Coordinate site visits, audits, and FDA inspections
- Mentor junior staff and optimize clinical workflows
- Analyze study data and prepare regulatory submissions
Qualifications
- Bachelor's degree in Nursing, Pharmacy, Life Sciences, or related field (Master's preferred)
- 5+ years of clinical research coordination experience in oncology trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Deep understanding of ICH-GCP, FDA regulations, and 21 CFR compliance
- Exceptional organizational skills with meticulous attention to detail
- Strong written and verbal communication abilities
- Experience with site initiation, monitoring, and closeout processes