Job Description
Join BioPharm Innovations, a leader in cutting-edge pharmaceutical research, as we revolutionize drug development pipelines. We're seeking a Senior Clinical Research Associate to oversee critical clinical trials from protocol design to final regulatory submission. This role offers the opportunity to work with groundbreaking therapies while collaborating with top-tier scientists in our state-of-the-art Cambridge facility.
What We Offer:
- Comprehensive benefits package including 401(k) matching
- Professional development stipend
- Hybrid work model with flexible scheduling
- Competitive compensation and equity opportunities
Responsibilities
- Design and execute Phase I-IV clinical trial protocols ensuring GCP compliance
- Monitor investigational sites for regulatory adherence and data integrity
- Lead cross-functional teams including biostatisticians and medical writers
- Prepare regulatory submissions (INDs, NDAs) for FDA/EMA review
- Analyze clinical data and prepare safety reports for regulatory bodies
- Develop risk mitigation strategies for complex trial designs
Qualifications
- MS/PhD in Life Sciences, Pharmacy, or related field
- 5+ years clinical research experience with 2+ years in CRA role
- Certified Clinical Research Professional (CCRP) certification required
- Proven expertise in oncology or immunology trials preferred
- Strong knowledge of ICH-GCP and FDA/EMA regulations
- Advanced proficiency in clinical trial management systems (e.g., Veeva Vault)