Job Description
Join BioVantage Therapeutics at the forefront of pharmaceutical innovation as a Clinical Research Associate. We're seeking a meticulous professional to ensure clinical trials adhere to regulatory standards while accelerating life-changing therapies to market. Our Boston hub offers state-of-the-art facilities and collaborative teams dedicated to advancing patient outcomes.
Responsibilities
- Monitor clinical trial sites for protocol compliance and regulatory adherence
- Conduct site visits, source document verification, and data quality audits
- Collaborate with investigators to resolve protocol deviations and ensure GCP compliance
- Prepare regulatory submissions and maintain comprehensive trial documentation
- Analyze clinical data trends and provide actionable insights to project teams
- Coordinate site initiation, interim monitoring, and close-out activities
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 3+ years of clinical monitoring experience in pharmaceutical/biotech
- Certified Clinical Research Associate (CCRA) certification required
- Deep knowledge of ICH-GCP, FDA, and EMA regulations
- Exceptional data management and audit trail documentation skills
- Strong problem-solving abilities with cross-functional team experience