Job Description
Join our pioneering team at BioPharm Innovations, where cutting-edge science meets compassionate patient care. As a Clinical Research Associate, you'll drive the future of medicine by ensuring clinical trials adhere to the highest ethical and scientific standards. Our Cambridge hub offers state-of-the-art facilities and collaborative culture focused on accelerating breakthrough therapies.
Responsibilities
- Monitor clinical trial sites to ensure protocol compliance and regulatory adherence
- Conduct site visits, source document verification, and data quality checks
- Collaborate with investigators to resolve protocol deviations and maintain study integrity
- Manage clinical trial documentation in compliance with FDA and ICH-GCP guidelines
- Coordinate site initiation, interim monitoring, and close-out activities
- Analyze study data and prepare comprehensive audit reports
- Maintain strong relationships with investigative sites and internal stakeholders
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 2+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Deep knowledge of ICH-GCP, FDA regulations, and clinical trial methodologies
- Exceptional communication skills for cross-functional collaboration
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Ability to travel up to 40% for site monitoring