Job Description
Join our award-winning team at Global Pharma Solutions Inc., a leader in innovative pharmaceutical research and development. As a Senior Clinical Research Associate, you'll drive the execution of global clinical trials, ensuring adherence to regulatory standards while advancing life-changing therapies. We offer competitive benefits, flexible work arrangements, and opportunities for professional growth in a cutting-edge environment.
Responsibilities
- Oversee clinical trial execution across multiple sites, ensuring compliance with GCP and FDA regulations
- Monitor site performance, conduct sponsor visits, and resolve protocol deviations
- Lead cross-functional teams to ensure timely trial milestones and data integrity
- Develop and maintain comprehensive study documentation (CRFs, IBs, SOPs)
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approvals
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in FDA/EMA regulations and ICH-GCP guidelines
- Strong data management and audit trail management skills
- Proven leadership experience in multi-site trials
- Excellent communication and problem-solving abilities