Job Description
Join BioPharm Innovations Inc., a pioneering biotechnology firm dedicated to accelerating therapeutic breakthroughs. We seek a Senior Clinical Research Associate to lead pivotal clinical trials and shape the future of medicine. This hybrid role offers the chance to work alongside world-class scientists while ensuring regulatory excellence and patient safety. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional growth in a dynamic, mission-driven environment.
Responsibilities
- Monitor clinical trial sites to ensure protocol adherence and data integrity
- Manage vendor relationships and oversee clinical trial budgets
- Prepare regulatory submissions (INDs, NDAs) and ensure GCP compliance
- Lead cross-functional teams to troubleshoot trial deviations
- Analyze clinical data and prepare safety reports for regulatory bodies
- Collaborate with biostatisticians on study design and endpoint validation
- Mentor junior CRAs and implement process improvements
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience in pharmaceutical/biotech
- ICH-GCP and FDA regulations expertise
- Proven track record in site monitoring and vendor management
- Certified Clinical Research Associate (CCRA) or equivalent
- Strong proficiency in EDC systems (e.g., Medidata Rave)
- Exceptional communication and problem-solving skills
- Ability to travel 25-30% domestically