Cdx Principal Investigator

The Principal Investigator (PI) is the primary individual responsible for the preparation, conduct, and administration of the Companion Diagnostic (CDx) research study sponsored by the Pharmaceutical companies and the Diagnostic device manufacturers companies (diagnostic sponsor)_
- The Principal Investigator ensures that good clinical laboratory practices are followed and that these are_
- consistent with the aims of the clinical research component for the pharmaceutical sponsor. _
- The Principal Investigator ensures that all research is conducted in an ethical manner and in accordance with all federal, state, and local laws and regulations, institutional policies, and the requirements of accrediting and regulatory agencies that affect Labcorp CLS laboratory operations_
- The Principal Investigator is responsible for the research studies conducted at his CLS site location across all laboratories disciplines and departments_
- The Principal Investigator delegates CDx study-related tasks as appropriate, but must adequately supervise personnel to whom tasks are delegated. The PI works closely with the Labcorp Diagnostic Development Services (DDS) Study Team_
- Coordinator who is responsible for the day-to-day operations related to the CDx Study Protocol and the local laboratory management team_
- The Principal Investigator ensures compliance with CDx study research protocol and Standard Operational Procedures(SOP)_

**_ CDx Study Research Oversight _**
- Ensure that CDx study personnel are qualified by training and experience to perform delegated study related tasks
- Ensure that CDx study personnel have an adequate understanding of the testing protocol; and CDx study personnel follow the protocol provided by the diagnostic sponsor and testing of clinical samples in accordance with the protocol of the pharmaceutical sponsor.
- Maintain close communication with the Clinical Research Associate (CRA) for the diagnostic sponsor and other the key representatives of both the diagnostic sponsor and the pharmaceutical sponsor of the research.
- Develop a plan for supervision and oversight of the research. The intensity of the

supervision should take into consideration the study personnel conducting the research, and the

nature of the research.
- Maintain close communication with other PIs overseeing the CDx study research in other Labcorp lab locations conducting the same global drug clinical trial to ensure consistencies and address study matters with a global approach
- In collaboration with local CLS lab management, assign a Co-Principal Investigator or Co-Investigator who have responsibilities similar to that of a PI on research projects. While the PI has ultimate responsibility for the conduct of a research project, the Co-PI/Co-I is also obligated to ensure the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.
- Work in close collaboration with Labcorp CLS Pharma Sponsor and the DDS Global Study Managers for all study related aspects that are pertaining to the CDx research study and through all study stages, from pre win to CDx research study closure
- Act as ambassador on behalf of the diagnostic sponsor across Labcorp CLS departments; exemplifies the concept of Signature Client Service through outstanding, personalized customer service skills.
- Able to act efficiently in an environment with dynamic timelines and priorities
- Demonstrate strong interpersonal and communication skills that will build strong internal and external relationships

**_ Principal responsibilities_**
- Signed Investigator Agreement (and Financial Disclosure form) required for all investigators/pathologists evaluating slides for clinical studies-This document must be signed prior to the start of the study and prior to start any patient testing from clinical studies
- The research is conducted in accordance with the CDx research protocol and consistent

with the clinical study protocol provided by the pharmaceutical company;
- Staff training on the CDx protocol is completed and documented prior to initiation of the
- New laboratory staff and pathologists are trained and qualified by the device sponsor before they are permitted to perform CDx testing
- New laboratory staff, pathologists and DDS team is trained on the CDx research protocol
- CDx reagent systems are accounted for their receipt, use and disposal as needed and according to the CDx research protocol requirements, and when devices are being investigated or used, they are managed and controlled as required by Labcorp CLS policy and, when applicable, FDA regulations 21 CRF 312 and 21 CFR 812;
- Unanticipated problems including adverse events are reported promptly to diagnostic sponsor primarily and the pharmaceutical sponsor;
- In consultation with Labcorp CLS Quality Assurance Department and the diagnostic sponsor, notifications to the IRB and ECs are provided as needed to ensure comp