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About the Role

The Clinical Research Associate I (CRA I) supports the successful conduct of clinical research studies by performing site monitoring and management activities, ensuring compliance with protocols, regulations, GCP, and ICH guidelines. This role is essential for protecting patient safety, ensuring data quality, and maintaining study integrity.

Responsibilities

• Conduct site selection, initiation, routine monitoring, and close-out visits.
• Evaluate the quality and integrity of site practices.
• Verify study activities align with regulatory requirements and sponsor expectations.
• Escalate quality concerns as necessary.
• Review essential documents.
• Assess protocol adherence.
• Oversee data entry and query resolution.
• Ensure maintenance of 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-level challenges.
• Support recruitment planning to meet enrollment targets.
• Collaborate with internal project teams for cohesive study execution.
• Contribute to site-level financial processes or start-up activities as needed.
• Prepare detailed monitoring visit reports, follow-up letters, and study documentation.
• Ensure audit readiness and transparent oversight.
• Manage multiple tasks, prioritize effectively, and work independently.
• Maintain productive team relationships.

Requirements

• Minimum of 6 months of on-site monitoring experience.
• Experience monitoring in oncology solid tumor.
• Ability to travel as required by the project.
• Bachelor’s degree required; a scientific or healthcare discipline is preferred.
• 6 months – 2 years of relevant experience, with equivalent combinations of education, training, or completion of a CRA training program considered.
• Basic knowledge of clinical research regulations (GCP/ICH).

Skills

• On-site monitoring
• Oncology solid tumor monitoring
• Site selection
• Site initiation
• Routine monitoring
• Close-out visits
• Regulatory compliance
• Good Clinical Practice (GCP)
• ICH guidelines
• Data quality assurance
• Study integrity
• Essential document review
• Protocol adherence assessment
• Data entry oversight
• Query resolution
• Trial Master File (TMF) maintenance
• Investigator Site File (ISF) maintenance
• Investigative site communication
• Protocol training
• Site-level challenge resolution
• Recruitment planning support
• Internal project team collaboration
• Study execution
• Site-level financial processes
• Start-up activities
• Documentation
• Monitoring visit report preparation
• Follow-up letter preparation
• Task management
• Prioritization
• Independent work
• Team collaboration

Work Type

• Full-time

Experience Level

• CRA 1
• 6 months – 2 years of relevant experience

Education Level

• Bachelor’s degree required; a scientific or healthcare discipline is preferred.

Salary/Compensations

• $71,900.00 - $145,300.00

Benefits

• Range of health and welfare and/or other benefits

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.
• 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.

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.