Job Description
Join BioVita Innovations, a pioneering biopharmaceutical leader transforming patient outcomes through groundbreaking therapies. We seek a Senior Clinical Research Associate to drive excellence in clinical trial execution while ensuring compliance with global regulatory standards. This role offers the opportunity to shape the future of medicine in an environment that values innovation, collaboration, and scientific rigor.
Responsibilities
- Monitor clinical trial sites to ensure protocol adherence, data integrity, and regulatory compliance (GCP, FDA, ICH guidelines)
- Lead site initiation, interim monitoring, and close-out visits with exceptional attention to detail
- Collaborate with cross-functional teams (CRA, medical, operations) to resolve study issues proactively
- Manage site performance metrics and provide mentorship to junior CRAs
- Conduct risk-based monitoring strategies using electronic data capture systems
- Prepare and submit comprehensive site visit reports with actionable recommendations
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials in therapeutic areas
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven expertise in FDA audits, 483 responses, and regulatory documentation
- Strong proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional problem-solving skills and ability to navigate complex operational challenges