Job Description
Join BioMed Solutions Inc., a leader in groundbreaking pharmaceutical research, as we pioneer next-generation therapies for global health challenges. We seek a dedicated Senior Clinical Research Associate to oversee complex clinical trials from protocol design to final reporting. This role offers the opportunity to work with cutting-edge treatments while ensuring regulatory compliance and data integrity in a collaborative, innovation-driven environment.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials adhering to ICH-GCP standards
- Lead site selection, initiation, and management of investigational sites across North America
- Ensure protocol compliance and audit preparation for FDA/EMA submissions
- Analyze clinical data and prepare comprehensive study reports for regulatory bodies
- Collaborate with cross-functional teams (medical, regulatory, biostatistics) to drive trial milestones
- Maintain electronic trial master files and ensure data accuracy per 21 CFR Part 11
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field (PhD preferred)
- 5+ years of clinical research experience with at least 2 years in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in eCRF systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of FDA/EMA regulations and ICH guidelines
- Exceptional problem-solving skills with attention to regulatory nuances