Job Description
Join BioPharm Innovations, a leader in cutting-edge pharmaceutical research, as we pioneer next-generation therapies. We seek a dynamic Senior Clinical Research Associate to drive our clinical trials from protocol to approval. This role offers unparalleled opportunities to shape the future of medicine while collaborating with world-class scientists in our state-of-the-art Boston facility. Enjoy competitive compensation, comprehensive benefits, and a culture that values innovation and impact.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials ensuring GCP compliance and regulatory adherence
- Serve as primary liaison between investigative sites, sponsors, and internal stakeholders
- Oversee site selection, initiation, and closeout activities with 20+ clinical sites annually
- Analyze complex clinical data to identify trends and prepare regulatory submissions
- Lead cross-functional teams including medical monitors, data managers, and biostatisticians
- Develop and maintain risk-based monitoring strategies for trial optimization
Qualifications
- Master's degree in life sciences, clinical research, or related field (PhD preferred)
- Minimum 5 years clinical research experience with 3+ years in CRA role
- ICH-GCP/FDA/EMA regulatory expertise and proven audit management
- Advanced proficiency in eClinical solutions (e.g., Medidata Rave, Veeva Vault)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Demonstrated success in managing complex multi-site oncology trials
- Exceptional communication skills and ability to navigate global regulatory landscapes