Job Description
Join Boston Medical Innovations as a Lead Clinical Research Coordinator and revolutionize patient care through cutting-edge clinical trials. We're seeking a visionary leader to orchestrate multi-site studies, mentor research teams, and ensure regulatory excellence in our quest to develop breakthrough therapies for chronic conditions. This hybrid role offers competitive benefits, flexible scheduling, and opportunities to present findings at international conferences.
Responsibilities
- Design and execute Phase II-III clinical trials across 5+ sites with 100% protocol adherence
- Mentor 8+ research coordinators on GCP compliance and data management best practices
- Collaborate with FDA and IRB to maintain 100% audit-ready documentation
- Implement EDC systems to reduce data errors by 40% and accelerate trial timelines
- Present outcomes to C-suite stakeholders and pharmaceutical partners
- Develop SOPs for rare disease studies using real-world evidence
- Manage $2M+ research budgets with quarterly financial reviews
Qualifications
- Master's degree in Clinical Research, Nursing, or related field
- 5+ years coordinating FDA-regulated trials with 3+ in leadership roles
- Certification in clinical research (ACRP or SOCRA)
- Expertise in EDC systems (Medidata Rave or Veeva Vault)
- Proven success in managing multi-center oncology or neurology trials
- Experience training investigators on complex protocol amendments
- Strong knowledge of 21 CFR Part 11 and ICH-GCP guidelines