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About the Role

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.

Responsibilities

Conduct site visits (selection, initiation, monitoring, close-out) in alignment with contracted scope, GCP, and ICH guidelines.
Collaborate with site staff on subject recruitment strategies to meet project timelines and enrollment goals.
Provide protocol and study-specific training to site personnel and maintain communication to manage expectations and resolve issues.
Assess site performance and protocol adherence, escalating quality concerns to ensure compliance and data integrity.
Monitor study progress by tracking regulatory submissions, subject enrollment, CRF completion, and data query resolution.
Ensure essential documents are collected and maintained in TMF and ISF according to regulatory standards.
Document site management activities, visit outcomes, and follow-up actions via detailed reports and correspondence.
Collaborate with cross-functional project teams to support study execution and align with project goals.
Support site-level recruitment planning and financial management, including invoice collection and budget tracking, as needed.

Requirements

Strong understanding of GCP, ICH guidelines, and regulatory requirements.
Ability to travel as required.
Experience monitoring in oncology solid tumor.

Skills

On-site monitoring
Oncology solid tumor monitoring
Good Clinical Practice (GCP)
ICH guidelines
Regulatory requirements
Subject recruitment strategy implementation
Protocol and study-specific training delivery
Site performance assessment
Quality concern escalation
Regulatory submission tracking
Subject enrollment tracking
Case Report Form (CRF) completion tracking
Data query resolution
Trial Master File (TMF) maintenance
Investigator Site File (ISF) maintenance
Site management activity documentation
Financial management (invoice collection, budget tracking)

Experience Level

Minimum 1 year of on-site monitoring experience.
Minimum 6 months of on-site monitoring experience (for CRA 1 candidates).

Education Level

Bachelor’s degree in life sciences or health-related field.
Equivalent experience.

Salary/Compensations

$71,900.00 - $169,300.00

Benefits

Incentive plans, bonuses, and other forms of compensation.
Health and welfare benefits.

About the Company

IQVIA Biotech is a full-service CRO dedicated to serving biotech sponsors.
With over 25 years of experience, IQVIA Biotech offers agile, therapeutically aligned solutions and trusted partnerships to accelerate breakthrough treatments to patients.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries.
IQVIA creates intelligent connections to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.
IQVIA seeks diverse talent with curious minds and a relentless commitment to innovation and impact.
Everyone at IQVIA contributes to the shared goal of helping customers improve the lives of patients everywhere.

Equal Opportunity

IQVIA is an equal opportunity employer, providing 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 maintains a zero-tolerance policy for candidate fraud, requiring all submitted information and credentials to be truthful and complete.
False statements, misrepresentations, or material omissions during recruitment will result in immediate disqualification or termination of employment.