Job Description
Join BioPharm Innovations as a Senior Clinical Research Associate and drive groundbreaking therapeutic solutions in cardiovascular medicine. We're seeking a passionate professional to lead pivotal clinical trials across the Northeast, ensuring regulatory excellence and patient safety while advancing our mission to transform global healthcare. Enjoy competitive benefits, cutting-edge research resources, and collaboration with industry leaders in our state-of-the-art Boston facility.
Responsibilities
- Oversee site management for Phase II-III cardiovascular clinical trials across 8-10 investigational sites
- Conduct comprehensive site monitoring visits ensuring 100% GCP/ICH compliance
- Lead protocol development and FDA regulatory document submissions
- Train investigators and site staff on clinical trial procedures and documentation
- Manage safety reporting and adverse event resolution per FDA guidelines
- Analyze clinical data and prepare interim reports for stakeholders
- Collaborate with cross-functional teams (medical, biostatistics, regulatory affairs)
Qualifications
- Master's degree in Pharmacy, Nursing, or Life Sciences with 5+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Demonstrated expertise in cardiovascular therapeutic area protocols
- Proven track record in FDA audit preparation and inspection management
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional data management and risk-based monitoring skills
- Strong leadership experience managing CRO relationships and site networks