Job Description
Join our pioneering healthcare team at MediCare Innovations, where cutting-edge research meets compassionate patient care. We're seeking a Senior Clinical Research Coordinator to lead critical trials that advance medical science while transforming patient outcomes. This hybrid role offers the perfect blend of hands-on clinical oversight and strategic protocol management in our state-of-the-art Boston facility.
As a key member of our Research Division, you'll collaborate with renowned physicians, biostatisticians, and regulatory experts to ensure seamless trial execution. We offer competitive benefits, professional development stipends, and an environment where your expertise directly impacts lives. MediCare Innovations is committed to fostering diversity, equity, and inclusion in clinical research.
Responsibilities
- Oversee end-to-end management of Phase II-III clinical trials, including protocol development, site initiation, and regulatory compliance
- Coordinate multidisciplinary teams of physicians, nurses, and data specialists to ensure protocol adherence and data integrity
- Monitor patient recruitment progress and implement strategic outreach plans to meet enrollment targets
- Maintain accurate regulatory documentation and ensure compliance with FDA, GCP, and ICH guidelines
- Analyze trial data and prepare comprehensive reports for IRB submissions and sponsor communications
- Lead investigator meetings and training sessions to optimize trial procedures and safety protocols
- Collaborate with biostatisticians on interim analyses and protocol amendments
Qualifications
- Master's degree in Nursing, Public Health, or Clinical Research with 5+ years of trial coordination experience
- Certified Clinical Research Professional (CCRP) or ACRP certification required
- Proven expertise in oncology or rare disease therapeutic areas
- Demonstrated success in managing multi-center trials with 50+ participants
- Advanced knowledge of electronic data capture systems (REDCap, Medidata Rave)
- Exceptional organizational skills with meticulous attention to regulatory documentation
- Strong analytical abilities for interpreting complex clinical data and safety reports
- Experience training investigators and site staff on GCP and trial-specific procedures