Job Description
Join BioVance Therapeutics, a pioneering biopharmaceutical company dedicated to developing transformative therapies for rare diseases. We are seeking a Senior Clinical Research Associate to lead critical clinical trials and ensure regulatory compliance across our innovative pipeline. This role offers the opportunity to shape the future of medicine while working with cutting-edge science in a collaborative, fast-paced environment.
Responsibilities
- Monitor clinical trial sites for compliance with FDA regulations, ICH-GCP, and protocol requirements
- Conduct site visits, source data verification, and audit clinical documentation
- Manage relationships with investigative sites, sponsors, and regulatory authorities
- Oversee clinical data integrity and ensure timely resolution of protocol deviations
- Prepare and review essential regulatory documents including IBs, safety reports, and study amendments
- Lead cross-functional teams to ensure trial milestones and deliverables are met
- Contribute to process improvements for clinical trial execution and risk mitigation
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- Minimum 5 years of clinical research experience with 3+ years in CRA role
- Proven expertise in oncology or rare disease therapeutic areas
- Thorough knowledge of FDA 21 CFR Part 820, ICH-GCP, and clinical trial regulations
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Exceptional problem-solving skills with ability to navigate complex regulatory landscapes
- Proficiency in electronic data capture systems (e.g., Medidata Rave) and CTMS platforms
- Willingness to travel up to 40% for site visits and meetings