Job Description
Join MediTech Solutions as a Senior Clinical Research Coordinator and lead transformative healthcare initiatives in Boston's premier medical innovation hub. We're pioneering cutting-edge therapies for chronic diseases, and you'll be instrumental in ensuring clinical trials adhere to stringent regulatory standards while accelerating patient access to life-changing treatments. Collaborate with multidisciplinary teams, mentor junior staff, and shape the future of evidence-based medicine in a culture that values precision, compassion, and breakthrough innovation.
Responsibilities
- Design, implement, and oversee complex clinical trial protocols in compliance with FDA, GCP, and ICH guidelines
- Coordinate site initiation, patient recruitment, and data management across multi-center studies
- Lead regulatory submissions, ethics committee approvals, and audit readiness preparation
- Mentor 3+ junior coordinators and train staff on SOPs and trial-specific procedures
- Analyze trial data, prepare clinical study reports, and present findings to stakeholders
- Collaborate with biostatisticians, medical writers, and pharmaceutical partners
Qualifications
- Master's degree in Clinical Research, Nursing, or related health science field
- 5+ years of clinical trial coordination experience in therapeutic areas (oncology/cardiology preferred)
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Expertise in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Proven track record of successful FDA 483/audit resolutions
- Strong leadership experience managing cross-functional teams
- Exceptional communication skills with regulatory bodies and sponsors