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 concept to completion. In this pivotal role, you'll ensure regulatory compliance, monitor trial integrity, and collaborate with global stakeholders to accelerate life-changing treatments. Our Boston headquarters offers a collaborative environment where innovation meets impact, with competitive benefits and professional growth opportunities.
Responsibilities
- Monitor clinical trial sites to ensure adherence to protocols, GCP, and FDA regulations
- Coordinate site initiation, interim monitoring, and closeout visits
- Review and verify clinical data for accuracy, completeness, and compliance
- Prepare regulatory documents, study reports, and safety submissions
- Act as primary liaison between investigative sites and internal teams
- Identify and resolve protocol deviations, site issues, and data discrepancies
- Train site personnel on trial procedures and regulatory requirements
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in CRA role
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Expert knowledge of ICH-GCP, FDA regulations, and clinical trial processes
- Strong proficiency in EDC systems (e.g., Medidata Rave) and CTMS
- Exceptional problem-solving, communication, and organizational skills
- Ability to travel 40-50% domestically/internationally