Job Description
Join BioInnovate Therapeutics, a leader in innovative biopharmaceutical solutions, as a Senior Clinical Research Associate. You'll be pivotal in advancing breakthrough therapies through meticulous clinical trial management, ensuring compliance with FDA and GCP standards. Our Cambridge-based hub offers cutting-edge resources and collaborative teams dedicated to transforming patient outcomes.
Responsibilities
- Design and execute clinical trial protocols across Phase I-III studies
- Monitor site performance and resolve protocol deviations proactively
- Coordinate with CROs and investigative sites for seamless trial execution
- Analyze safety data and prepare regulatory submissions (IND/CTA)
- Mentor junior associates and optimize clinical trial processes
- Leverage eCRF systems for real-time data management
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (MS/PhD preferred)
- 5+ years of clinical research experience in pharmaceutical/biotech
- CRA certification (ACRP or SOCRA) required
- Expertise in oncology or autoimmune disease trials
- Advanced proficiency in EDC systems (e.g., Medidata Rave)
- Proven track record in FDA audit readiness
- Strong cross-functional leadership abilities