Job Description
Join BioPharm Innovations Inc., a leader in cutting-edge pharmaceutical research, as we pioneer life-changing therapies. We seek a passionate Senior Clinical Research Associate to drive our clinical trials from protocol to submission. This hybrid role offers the opportunity to work with world-class scientists while making tangible impacts on patient care. Our collaborative environment fosters innovation, and we provide comprehensive benefits including stock options and flexible work arrangements.
Responsibilities
- Oversee clinical trial execution across multiple sites ensuring protocol adherence and regulatory compliance (ICH-GCP)
- Conduct site monitoring visits, source data verification, and vendor management
- Lead risk-based monitoring strategies and implement eClinical solutions
- Mentor junior CRAs and collaborate with cross-functional teams (medical, regulatory, biostatistics)
- Manage trial documentation, maintain study files, and prepare regulatory submissions
- Analyze clinical data trends and contribute to safety signal detection
- Represent company at investigator meetings and external conferences
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) certification required
- Proven expertise in risk-based monitoring and eClinical systems (e.g., Medidata Rave)
- Strong knowledge of FDA regulations, ICH-GCP, and global clinical trial standards
- Exceptional communication skills for stakeholder management and conflict resolution
- Ability to travel up to 40% and manage competing priorities in dynamic environments
- Experience with oncology or rare disease trials highly desirable