Job Description
Join BioPharm Innovations Inc., a leader in cutting-edge pharmaceutical research, as we pioneer next-generation therapies to transform global healthcare. Our Cambridge-based team is seeking a dynamic Senior Clinical Research Associate to drive critical clinical trials from protocol to submission. You'll collaborate with cross-functional teams to ensure regulatory compliance, data integrity, and patient safety while advancing breakthrough treatments. This role offers competitive compensation, comprehensive benefits, and the opportunity to shape the future of medicine in an innovative, science-driven environment.
Responsibilities
- Oversee clinical trial execution and site monitoring to ensure compliance with FDA regulations and GCP standards
- Manage site relationships, conduct monitoring visits, and resolve protocol deviations proactively
- Analyze clinical data, prepare regulatory submissions, and maintain trial documentation
- Collaborate with medical, regulatory, and data teams to optimize trial design and execution
- Lead risk-based monitoring strategies and implement quality management systems
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with at least 2 years in CRA roles
- ICH-GCP and FDA regulatory knowledge with proven compliance track record
- Certified Clinical Research Associate (CCRA) certification required
- Experience with EDC systems (e.g., Medidata Rave) and risk-based monitoring
- Exceptional communication skills for cross-functional collaboration
- Strong problem-solving abilities and attention to detail