Job Description
Join our pioneering team at BioPharm Innovations Inc. as a Senior Clinical Research Associate and drive the future of healthcare innovation. We're seeking a dynamic professional to oversee critical clinical trials for groundbreaking therapeutics in oncology and rare diseases. This role offers the opportunity to work with industry-leading experts while contributing to life-changing medical breakthroughs.
Our Boston-based headquarters is at the heart of the global biotech ecosystem, offering unparalleled networking opportunities and access to cutting-edge research facilities. We provide comprehensive benefits including flexible work arrangements, professional development stipends, and competitive health coverage.
Responsibilities
- Design and execute clinical trial protocols ensuring compliance with FDA regulations and GCP standards
- Monitor trial sites to verify data integrity and protocol adherence
- Coordinate cross-functional teams including physicians, statisticians, and regulatory specialists
- Analyze clinical data and prepare comprehensive regulatory submissions
- Mentor junior associates and optimize clinical trial processes
- Lead investigator meetings and ensure site readiness for audits
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field with 5+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Demonstrated expertise in oncology or rare disease therapeutic areas
- Proficiency in eCRF systems (e.g., Medidata Rave) and clinical databases
- Strong knowledge of ICH-GCP, FDA 21 CFR Part 820, and EU regulatory requirements
- Exceptional problem-solving skills with attention to detail
- Proven ability to manage multiple complex trials simultaneously