Job Description
Join BioGenix Pharmaceuticals, a global leader in innovative therapeutics, as a Senior Clinical Research Associate. You'll drive excellence in clinical trials from protocol design to study closure, ensuring regulatory compliance and data integrity while advancing life-changing treatments for patients worldwide.
This pivotal role offers the opportunity to work with cutting-edge therapies in a collaborative, science-driven environment. You'll partner with cross-functional teams including medical monitors, data managers, and regulatory affairs specialists to accelerate drug development timelines while maintaining the highest ethical standards.
We provide comprehensive benefits including competitive compensation, flexible work arrangements, and continuous professional development opportunities. If you're passionate about transforming healthcare through rigorous clinical research, we invite you to apply.
Responsibilities
- Conduct comprehensive site initiation, interim, and closeout visits ensuring GCP/ICH compliance
- Monitor clinical trial progress, data quality, and protocol adherence at investigational sites
- Manage site relationships, investigator training, and issue resolution for complex therapeutic areas
- Oversee clinical data verification, discrepancy management, and regulatory document submissions
- Collaborate with CROs and site personnel to optimize trial execution and patient recruitment
- Develop and maintain study-specific documentation including informed consent forms and study manuals
- Lead risk-based monitoring strategies and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in life sciences, nursing, or related field; Master's or PhD preferred
- Minimum 5 years clinical research experience with 3+ years in CRA role
- Deep expertise in ICH-GCP, FDA regulations, and global clinical trial requirements
- Proven track record in managing Phase II-III trials in therapeutic areas (Oncology/CNS preferred)
- Advanced proficiency in EDC systems (Medidata Rave, Veeva Vault) and eTMF platforms
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Exceptional problem-solving skills with ability to navigate complex regulatory landscapes