Job Description
Join BioPharm Innovations as a Senior Clinical Research Associate and lead groundbreaking studies that transform patient care. We're seeking a dedicated professional to oversee clinical trials for our novel oncology therapies, ensuring compliance with FDA regulations and GCP standards. Enjoy competitive compensation, comprehensive benefits, and the opportunity to work with world-class researchers in a dynamic, collaborative environment.
Responsibilities
- Design and implement clinical trial protocols for Phase II-III oncology studies
- Monitor investigational sites for protocol adherence and regulatory compliance
- Manage clinical data collection, verification, and regulatory submissions
- Liaise with ethics committees and regulatory authorities
- Train site staff on trial procedures and documentation requirements
- Analyze adverse events and ensure patient safety protocols
- Prepare FDA submissions and maintain audit-ready documentation
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience in oncology trials
- CRA certification (ACRP or SoCRA)
- Deep knowledge of FDA regulations, ICH-GCP, and clinical trial protocols
- Experience with EDC systems (e.g., Medidata Rave) and CTMS platforms
- Strong analytical skills and attention to detail
- Exceptional communication and stakeholder management abilities
- Ability to travel 30-40% to clinical sites