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About the Role

The Clinical Research Associate I (CRA I) supports clinical research studies by performing site monitoring and management. This role ensures sites comply with protocols, regulations, GCP, and ICH guidelines, protecting patient safety and data integrity.

Responsibilities

• Conduct site selection, initiation, routine monitoring, and close-out visits.
• Evaluate site quality and integrity, ensuring compliance with regulations and sponsor expectations.
• Review essential documents, assess protocol adherence, and oversee data entry and query resolution.
• Maintain the Trial Master File (TMF) and Investigator Site File (ISF).
• Build and maintain strong communication with investigative sites.
• Provide protocol training, set expectations, and address site challenges.
• Support recruitment planning to help sites meet enrollment targets.
• Collaborate with internal project teams for cohesive study execution.
• Prepare detailed monitoring visit reports, follow-up letters, and study documentation.
• Manage multiple tasks, prioritize effectively, and work independently.

Requirements

• Minimum of 6 months of on-site monitoring experience.
• Experience monitoring in oncology solid tumor.
• Ability to travel as required by the project.

Skills

• Basic knowledge of clinical research regulations (GCP/ICH).

Location

• Remote

Work Type

• Full-time

Experience Level

• 6 months – 2 years of relevant experience
• Equivalent combinations of education, training, or completion of a CRA training program considered.

Education Level

• Bachelor’s degree required
• Scientific or healthcare discipline preferred.

Salary/Compensations

• $71,900.00 - $145,300.00

Benefits

• Health and welfare benefits
• Incentive plans
• Bonuses

About the Company

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

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.
• 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.