Clinical Research Associate, Early Clinical Development

IQVIA; Sacramento (CA); Presencial; USD 90.000 - 175.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a dedicated Clinical Research Associate (CRA) to join our Early Clinical Development team working across US sites on Phase I trials. You will monitor and manage clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations.

This role requires on-site monitoring experience, travel, and the ability to collaborate with cross-functional teams to support trial execution, data integrity, and TMF/ISF documentation in line with GCP and ICH

Formación

• Bachelor's degree in life sciences or health-related field or equivalent experience.
• 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.

Responsabilidades

• Conduct site visits (selection, initiation, monitoring, close-out) per GCP/ICH.
• Collaborate with site staff to implement recruitment strategies.
• Deliver protocol training to site personnel and maintain clear communication.
• Assess site performance and escalate quality concerns as needed.
• Monitor study progress: regulatory submissions, enrollment, CRFs, data queries.
• Ensure TMF and ISF documentation meets regulatory standards.
• Document site activities and outcomes through reports and correspondence.
• Work with cross-functional teams to support study execution and budgets.

Conocimientos

GCP

ICH guidelines

Regulatory requirements

Travel availability

On-site monitoring

Educación

Bachelor's degree in life sciences or health-related field

Descripción del empleo

IQVIA is now hiring for Clinical Research Associates located on the West Coast and East 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 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. Learn more at https://jobs.iqvia.com

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.