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About the Role
We are seeking a dedicated Clinical Research Associate (CRA) to join our Early Clinical Development team, focusing exclusively on Phase I trials. You will play a key role in ensuring the successful execution of clinical trials by monitoring and managing clinical sites for compliance with protocols, regulations, and sponsor expectations, contributing to the integrity and quality of clinical research data.
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.
- Support site-level recruitment planning and financial management, including invoice collection and budget tracking, depending on the project.
Requirements
- Requires at least 1.5 years of on-site monitoring experience.
- Ability to travel as required by the project.
- 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.
Skills
- Strong understanding of GCP, ICH guidelines, and regulatory requirements.
Location
- West Coast, US
- East Coast, US
Work Type
- Full-time
Experience Level
- 1.5+ years of on-site monitoring experience
Education Level
- Bachelor’s degree in life sciences or health-related field (or equivalent experience).
Salary/Compensations
- $90,200.00 - $175,100.00
Benefits
- Range of health and welfare and/or other benefits
- Incentive plans
- Bonuses
About the Company
- 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
Equal Opportunity
- 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