CRA 2, Early Clinical Development

IQVIA; Carlsbad (CA); On-site; USD 90,200 - 150,400; Full time

Job summary

IQVIA is hiring a Clinical Research Associate (CRA) in Carlsbad, California. The CRA will manage clinical sites and ensure compliance with protocols. Responsibilities include oversight of site visits, collaboration with staff for recruitment, and monitoring project progress.

Candidates should have a Bachelor's in life sciences and at least 1.5 years of on-site monitoring experience. The position offers a competitive salary range of $90,200 - $150,400, along with additional compensation and benefits.

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.

Responsibilities

• Conduct all types of site visits: selection, initiation, monitoring, and close-out.
• Collaborate with site staff to implement subject recruitment strategies.
• Deliver study-specific training to site personnel and manage expectations.
• Assess site performance and adherence to the protocol, escalating issues.
• Monitor study progress by tracking submissions, enrollment, and queries.
• Ensure essential documents are maintained according to regulatory standards.
• Document site management activities, visit outcomes, and follow-up actions.
• Support cross-functional project teams to ensure alignment with goals.
• Support recruitment planning and financial management as needed.

Skills

GCP knowledge

ICH guidelines

On-site monitoring experience

Ability to travel

Education

Bachelor’s degree in life sciences

Job description

IQVIA Biotech is now hiring for CRA 2 with a minimum of 1.5 years of onsite monitoring, and early phase experience preferred.

IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster.

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.

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.

The potential base pay range for this role, when annualized, is $90,200.00 - $150,400.00. 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 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.