Job Description
Join our pioneering team at BioPharm Innovations Inc., where we're revolutionizing drug development through cutting-edge clinical trials. As a Senior Clinical Research Associate, you'll drive the execution of complex Phase II-III oncology studies, ensuring regulatory compliance and data integrity. Collaborate with cross-functional teams to accelerate life-changing therapies to market while maintaining our unwavering commitment to patient safety and scientific excellence. Enjoy competitive benefits, flexible work arrangements, and continuous professional development in a culture that values innovation and impact.
Responsibilities
- Oversee site initiation, monitoring, and closure for multi-center oncology clinical trials
- Ensure protocol adherence and regulatory compliance (FDA, ICH-GCP)
- Conduct site visits, source data verification, and audit management
- Collaborate with medical monitors to resolve clinical and operational issues
- Maintain accurate electronic trial master files and regulatory documentation
- Lead investigator meetings and training sessions for study sites
- Analyze clinical data trends and prepare comprehensive monitoring reports
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with oncology trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in FDA and ICH-GCP regulations
- Exceptional data management and audit trail documentation skills
- Strong problem-solving abilities in cross-functional team environments
- Experience with electronic data capture systems (e.g., Medidata Rave)
- Excellent written and verbal communication skills