Senior Clinical Research Associate, Early Clinical Development
iqvia · Carlsbad
Job description
About the role
iQVIA is hiring a Senior Clinical Research Associate for its Early Clinical Development team on the US West Coast, working exclusively in Phase I trials. You will monitor and manage clinical sites to ensure compliance with study protocols, regulatory requirements and sponsor expectations, contributing directly to the integrity and quality of clinical research data.
Key responsibilities
- Conduct site selection, initiation, monitoring and close-out visits in line with the contracted scope of work, GCP and ICH guidelines.
- Work with site staff to implement and track subject recruitment strategies aligned with project timelines and enrollment goals.
- Deliver protocol and study-specific training to site personnel and keep communication open to manage expectations and resolve issues.
- Assess site performance and adherence to the protocol, escalating quality concerns as needed.
- Monitor study progress by tracking regulatory submissions, subject enrollment, CRF completion and resolution of data queries.
- Ensure documents are collected and kept in the Trial Master File (TMF) and Investigator Site File (ISF) according to regulatory standards.
- Document site management activities, visit outcomes and follow-up actions in reports and correspondence.
- Work with cross-functional project teams; depending on the project, support site-level recruitment planning, financial management, invoice collection and budget tracking.
Required profile
- Bachelor's degree in life sciences or a health-related field (or equivalent experience).
- At least 1.5 years of on-site monitoring experience.
- Ability to travel as required by the project.
Required skills
- Strong understanding of GCP, ICH guidelines and regulatory requirements.
What we offer
- Potential base pay range of $90,200 to $175,100 per year, depending on qualifications, location and schedule.
- Depending on the position, incentive plans, bonuses and other forms of compensation may be offered, along with health and welfare benefits.
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Published 9 hours ago
Expires 1 month from now
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iqvia
Carlsbad
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