Senior Clinical Research Associate, Early Clinical Development

IQVIA LLC; Carlsbad (CA); On-site; USD 90,000 - 175,000; Full time

Job summary

IQVIA LLC on the West Coast seeks a Senior Clinical Research Associate to monitor Phase I trials and ensure site compliance with study protocols and regulatory requirements. You will manage site visits, communications, and data integrity to support successful trial execution.

The role requires at least 1.5 years of on-site monitoring experience, a life sciences degree, and the ability to travel as needed. You will work with cross-functional teams to ensure alignment with project timelines and

Qualifications

• Bachelor's degree in life sciences or health-related field.
• At least 1.5 years of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required.

Responsibilities

• Conduct on-site visits including initiation, monitoring, and close-out in line with GCP/ICH.
• Collaborate with site staff to support recruitment timelines and targets.
• Deliver protocol-specific training to site personnel and communicate clearly.
• Assess site performance and escalate quality issues to ensure data integrity.
• Track regulatory submissions, subject enrollment, CRF completion, and data queries.
• Maintain TMF and ISF documentation per regulatory standards.
• Document site activities and follow-up actions in detailed reports.
• Support cross-functional teams to align study execution and budgets.

Skills

GCP/ICH knowledge

On-site monitoring

Travel readiness

Regulatory compliance

Education

Bachelor’s degree in life sciences

Job description

IQVIA is now hiring for a Senior Clinical Research Associate located on the West Coast, US to join our growing Early Clinical Development team working exclusively in Phase I. Job Overview We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data.

Key Responsibilities

• Conduct all types of site visits- selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines.
• Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals.
• Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues.
• Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity.
• Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries.
• Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards.
• Document site management activities, visit outcomes, and follow‑up actions through detailed reports and correspondence.
• Work closely with cross‑functional project teams to support study execution and ensure alignment with project goals.
• Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking.

Qualifications

• Bachelor’s degree in life sciences or health-related field (or equivalent experience).
• Requires at least 1.5 years of on-site monitoring experience.
• Strong understanding of GCP, ICH guidelines, and regulatory requirements.
• Ability to travel as required by the project.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

https://jobs.iqvia.com/eoe

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $90,200.00 - $175,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.

We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.