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Principal Investigator, CDx

Aplica ya
Mapa de ubicación: Valencia, California, United States Full time R1300881

Descripción del trabajo

Job Overview
Principal Investigator is responsible for supervising CDx/IVD studies and protecting the rights, safety, and welfare of study subjects. A PI who conducts clinical investigations of medical devices, under 21 CFR Part 812, commit themselves to supervise all testing of the device involving human subjects. PI reads and signs the investigational plan that becomes contractually binding with the PI ultimately being held responsible for all deviations to the investigation plan.


• Cohost the initial Site Qualification Visit (SQV) with the support of Quality Assurance (QA) team.
• Conduct the investigational trial in accordance with the signed agreement with the Sponsor and the investigational plan.
• Adheres to the regulations set forth in 21CFR Part 812 and all other applicable FDA and other associated regulations.
• Protects the rights, safety, and welfare of subjects under the investigator's care.
• Controls devices under investigation.
• Ensures IRB/EC approval is obtained before starting the study and ensures adherence to the IRB/EC approval.
• Responsible for leading the SIV, Interim Monitoring Visit (IMV), and Close Out Visit (COV); and provides support and direction on monitoring findings.

• Ph.D. degree in Biological Science.
• Good understanding of ICH-GCP guidelines.
• Experience with CDx preferred.
• Experience in a regulated laboratory environment preferred.

• Understanding of the precision drug development industry preferred.
• Strong knowledge of good documentation practices.
• Strong written and verbal communication skills including good command of English language.
• Demonstrated ability to effectively prioritize and anticipate workload constraints.
• Strong attention to detail and accuracy.
• Demonstrated ability to work in a fast-paced environment.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Applicable certifications and licenses as required by local regulations.

Q² Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

As the COVID-19 virus continues to evolve, Q² Solutions' ability to operate and provide certain services to customers and partners necessitates Q² Solutions and its employees meet specific requirements regarding vaccination status.

Aplica ya

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