Job Description
Join BioPharm Innovations, a leader in groundbreaking therapeutics, as we pioneer the next generation of treatments for rare diseases. Our dynamic team is seeking a passionate Senior Clinical Research Associate to oversee critical clinical trials from protocol design to final report submission. You'll collaborate with cross-functional experts to ensure data integrity, regulatory compliance, and patient safety while driving innovation in clinical development. This role offers unparalleled opportunities to shape the future of medicine in a collaborative, growth-oriented environment.
Responsibilities
- Design and implement clinical trial protocols in alignment with FDA/EMA regulations and ICH-GCP standards
- Manage site relationships, monitor trial progress, and ensure protocol adherence across multiple global sites
- Oversee data collection, quality control, and analysis to maintain 99% data accuracy
- Lead regulatory submissions and ensure compliance with SOPs and ethical guidelines
- Mentor junior CRAs and contribute to process optimization initiatives
- Represent the company at investigator meetings and regulatory audits
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field with 5+ years clinical research experience
- Certified Clinical Research Associate (CCRA) or equivalent certification required
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced knowledge of FDA 21 CFR Part 312 and ICH-GCP guidelines
- Strong proficiency in EDC systems (e.g., Medidata Rave) and risk-based monitoring
- Exceptional communication skills with experience managing global site networks
- Track record of successful trial closure and regulatory approval submissions