
Senior Clinical Research Associate, Early Clinical Development, West/Central, IQVIA Biotech
- Carlsbad, CA
- $87,200-182,000 per year
- Permanent
- Full-time
We are seeking a detail-oriented and proactive Clinical Research Associate (CRA) to join our team. In this role, you will be responsible for monitoring clinical trial sites to ensure compliance with study protocols, regulatory guidelines, and sponsor requirements. Your work will directly support the integrity and success of clinical research projects.Key Responsibilities
- Conduct site visits including selection, initiation, monitoring, and close-out in accordance with Good Clinical Practice (GCP) and contractual obligations.
- Collaborate with sites to develop and manage subject recruitment strategies aligned with project timelines and goals.
- Deliver protocol and study-specific training to site staff and maintain consistent communication to address expectations and resolve issues.
- Assess site performance and compliance with regulatory standards, escalating quality concerns when necessary.
- Track study progress including regulatory submissions, subject enrollment, case report form (CRF) completion, and data query resolution.
- Ensure site documentation is properly maintained and filed in the Trial Master File (TMF) and Investigator Site File (ISF) per GCP and local regulations.
- Document site interactions and monitoring activities through visit reports, follow-up letters, and other required records.
- Partner with internal study teams to support project execution and resolve site-level challenges.
- May contribute to site-level recruitment planning and financial management, including invoice collection per trial agreements.
- Bachelor’s degree in a scientific or healthcare discipline is preferred.
- Minimum of 2 years of on-site monitoring experience required.
- Equivalent education, training, or experience may be considered.
- Strong understanding of clinical research regulations including GCP and ICH guidelines.