Job Description
Join our pioneering team at BioPharm Innovations Inc., where cutting-edge science meets transformative patient care. We're seeking a Senior Clinical Research Associate to drive our next-generation oncology trials from Boston's premier biotech hub. Shape the future of medicine while enjoying competitive compensation, comprehensive benefits, and unparalleled professional growth in a collaborative, innovation-driven environment.
Responsibilities
- Design and execute Phase I-III clinical trials ensuring GCP/ICH compliance
- Monitor investigative sites for protocol adherence and data integrity
- Lead cross-functional teams in trial startup and site activation
- Analyze clinical data and prepare regulatory submissions for FDA/EMA
- Develop risk-based monitoring strategies and vendor management protocols
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field with 5+ years clinical research experience
- Certified CRA (CCRA) or equivalent professional certification
- Proven expertise in oncology therapeutic area and oncology trial protocols
- Advanced knowledge of FDA 21 CFR Part 312, ICH-GCP, and regulatory requirements
- Exceptional data management and eCRF system proficiency (e.g., Medidata Rave)
- Strong leadership skills with demonstrated site management experience
- Excellent communication skills for stakeholder engagement and conflict resolution