Job Description
Join BioVita Innovations, a leader in cutting-edge pharmaceutical research, as we pioneer the next generation of life-changing therapies. We seek a passionate Senior Clinical Research Associate to drive excellence in clinical trial execution and regulatory compliance. This role offers the opportunity to work with top-tier scientists and contribute to breakthrough treatments while advancing your career in a dynamic, innovation-driven environment.
Responsibilities
- Oversee clinical trial execution across multiple sites, ensuring adherence to protocols, GCP, and FDA regulations
- Lead site initiation, monitoring, and closeout visits with meticulous documentation and issue resolution
- Collaborate with cross-functional teams (medical, regulatory, data management) to ensure trial milestones are met
- Manage and analyze clinical data, preparing comprehensive reports for internal stakeholders and regulatory bodies
- Mentor junior CRAs and implement process improvements to enhance trial efficiency
- Conduct risk assessments and develop mitigation strategies for trial-specific challenges
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with 3+ years in CRA role
- Proven expertise in ICH-GCP, FDA regulations, and clinical trial management systems
- Strong project management skills with ability to handle complex multi-site trials
- Exceptional communication and interpersonal skills for effective site and stakeholder management
- Certification as CRA (ACRP or SoCRA) required
- Experience with oncology or rare disease trials highly desirable