Job Description
Join BioPharm Innovations at the forefront of medical breakthroughs as a Clinical Research Associate. We're seeking a detail-oriented professional to oversee clinical trials and ensure regulatory compliance while driving innovation in pharmaceutical research. Enjoy competitive compensation, comprehensive benefits, and opportunities to shape the future of healthcare.
Responsibilities
- Monitor clinical trial sites for protocol adherence and data integrity
- Conduct site visits, audits, and vendor management
- Ensure compliance with FDA regulations and GCP standards
- Coordinate with investigators and sponsors for trial execution
- Prepare regulatory documentation and study reports
- Analyze clinical data and identify protocol deviations
- Maintain electronic trial master files (eTMF)
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field
- 2+ years of clinical research monitoring experience
- CRA certification (ACRP or SOCRA preferred)
- Strong knowledge of ICH-GCP and FDA regulations
- Exceptional attention to detail and documentation skills
- Ability to travel up to 30% domestically
- Experience with EDC systems (e.g., Medidata Rave)
- Excellent communication and problem-solving abilities