Job Description
Join BioPharm Innovations, a leader in cutting-edge pharmaceutical research, and drive the future of medicine as our Senior Clinical Research Associate. You'll orchestrate pivotal clinical trials from protocol to closeout, ensuring compliance with global regulatory standards while collaborating with cross-functional teams to accelerate therapeutic breakthroughs. This role offers unparalleled opportunity to shape clinical development strategies in a dynamic, innovation-driven environment.
Responsibilities
- Design and execute clinical trial protocols in compliance with ICH-GCP and FDA regulations
- Monitor investigational sites for protocol adherence, data integrity, and regulatory compliance
- Lead site selection, initiation, and closure activities across multi-center trials
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approval
- Coordinate cross-functional teams (medical, regulatory, biostatistics) to ensure trial milestones
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (ACRP/SoCRA) required
- Deep expertise in ICH-GCP, FDA/EMA regulations, and clinical trial management
- Proven track record in site management and regulatory submissions
- Exceptional problem-solving skills and attention to detail
- Strong proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)