Clinical Research Associate

$74,300 - $138,100/Yr

Roche - Tucson, AZ

Full-time - Mid Level

Tucson, AZ

10,001+ employees

Chemical Manufacturing

About the position

The Clinical Research Associate position at Roche involves managing site start-up activities for clinical studies, ensuring compliance with regulations and guidelines, and maintaining strong relationships with study sites and internal teams. The role is crucial for facilitating successful clinical trials that contribute to bringing Roche products to market, emphasizing the importance of stakeholder management and collaboration within diverse teams.

Responsibilities

• Ensure study/site compliance with applicable regulations and guidelines.
• Facilitate successful clinical trials by managing site start-up activities.
• Build and maintain strong relationships with cross-functional team members and external partners.
• Adhere to regulations, guidelines, and standard operating procedures for ongoing audit/inspection readiness.
• Execute Site Management activities for sponsored studies during the study start-up phase.
• Coordinate submissions to regulatory bodies, IRB, and ethics committees as needed.

Requirements

• Bachelor's degree in chemistry, biology, other life sciences or a related field.
• Experience or background in the IVD industry or similar positions.
• Knowledge of ICH/GCP and global regulatory guidelines/directives/IVDR.
• Experience in leading Sponsor and Site-related essential documents.
• Familiarity with engaging and coordinating third-party service providers (CROs, Labs, etc.).

Nice-to-haves

• Experience in clinical trials study start-up.
• Experience in clinical trial preparation, including IRB/Ethics Committee, ICFs, and contracts.
• Strong analytical skills and attention to detail.
• Ability to handle ambiguity and participate effectively in cross-functional teams.

Benefits

• Discretionary annual bonus based on individual and company performance.
• Comprehensive health insurance coverage.
• Paid time off and holidays.
• Opportunities for professional development and training.