CDx Principal Investigator (Companion Diagnostics)

Are you interested in making a real scientific impact through your everyday work Would you enjoy working in a team-focused environment as you explore unique career opportunities

If you are looking for a company where you can gain exposure to a wide variety of science and explore a multitude of career paths across the drug development spectrum consider working at Labcorp as a CDx Principal Investigator (Companion Diagnostics).

In this role you will be 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).

This position will be based onsite at our Torrance CA location.

In more details you will

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 key representatives of both the diagnostic sponsor and the pharmaceutical sponsor of the research.
• Develop a plan for supervision and oversight of 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 consistency and address study matters with a global approach
• In collaboration with local CLS lab management assign a Co-Principal Investigator or Co-Investigator who has responsibilities like 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
• Function 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
• Investigational Review Board (IRB) and local Ethical Committees applications are completed and approved prior to initiating the CDx study. (Site Initiation Visit hosted by the diagnostic sponsor)
• 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
• Protocol
• 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 sponsors 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 compliance with IRB and ECs requirements for reporting.
• Ensure that on-going review is conducted in conjunction with the CDx CRA or other representatives to ensure compliance with the CDx study protocol.
• All deviations to the CDx protocol as requested by the diagnostic sponsor or the pharmaceutical sponsor are reviewed and approved by the PI.
• Major deviations to the CDx protocol are reviewed and approved by the PI prior to the resumption of testing.
• PI participates in on-going conference calls and on-site audits by the diagnostic sponsor and
• the pharmaceutical sponsor.
• When the CDx study and the related clinical research are complete the PI is responsible for ensuring that a close out of the activities prior completion will be organized by Labcorp CDx study coordinator with the diagnostic sponsor and the pharmaceutical sponsor.
• The PI is responsible for ensuring adequate and accurate records are kept and retained as required by the diagnostic sponsor and the pharmaceutical sponsor and consistent with Labcorp CLS documentation practices.
• The PI in conjunction with Labcorp Quality Assurance Department Medical Affairs and
• Labcorp Lab Management ensures document retention and control and limited access to
• only those individuals who have a need to such records and when applicable and
• approved by the diagnostic sponsor the pharmaceutical sponsor and the Food and Drug Administration (FDA).
• The PI is responsible for hosting the Food and Drug Administration (FDA) Bioresearch Monitoring (BIMO) program inspection and oversee the coordination of the documentation gathering for regulatory inspections readiness in conjunction with Labcorp Quality Assurance Department and Diagnostic Development Services management

Day-to-day study related activities

• Review approval and sign initial CDx research protocol and subsequent amendments
• Sign Financial Disclosure Agreement
• Review and sign all regulatory documentation submitted to Ethical Committees and Institutional Review Boards
• Ensure that all individuals delegated are trained and qualified by the device sponsor or designer
• Document delegated tasks to appropriate lab staff and CDx research coordinator individuals in the delegation log
• Maintain Delegation log accuracy throughout the shelf-life retention period of the Device study
• Communicate critical changes to lab staff CDx research coordinator and any impacted operational teams as appropriate to ensure operational processes alignment
• Oversight of technical issues and troubleshooting during analytical performance verification and during the conduct of clinical trial
• Assess Report and submit Adverse Events and Protocol Deviations and ECs/IRBs as appropriate
• Review and sign Note to File Memos
• Oversight of data consistency and data integrity when electronic data transfer to the device sponsor is required in collaboration with the lab technical liaisons and data management team.
• Attend training site initiation visit monitoring visits closure visit
• Attend device sponsor and 3-way calls with pharmaceutical device sponsors and Labcorp CLS personal as appropriate

Thrive personally and professionally at Labcorp

Working at Labcorp you will continue to grow in our learning-based culture so you will know how to respond and adapt expertly as the industry continues to evolve. Here you will put your education to work as you play a meaningful role in advancing healthcare and making a difference in peoples lives.

In addition Labcorp offers great benefits global experience and the opportunity to work independently within a collaborative environment.

What we are looking for

CDx Principal Investigator (Companion Diagnostics) are most successful at Labcorp with:

Minimum Education and Experience Required:

• 3-4 years post-doctoral or industry experience within scientific area of expertise. Additional relevant experience may be substituted for education requirements below.
• Highly skilled in conducting research data interpretation and authoring reports.
• Experience performing scientific presentations and design/development of molecular assays and histopathology assays (IHC: Immunohistochemistry)
• Knowledge of clinical laboratory automation system software Microsoft applications and laboratory statistics.
• Experience working in a regulated environment preferred (GCP CAP CLIA)
• Effective communication skills with technical staff business development staff peers and clients.
• Mindfulness and interpretation of scientific data.
• Demonstrated problem prevention detection and resolution.

Preferred Education and Experience:

• Design and development of molecular assays and/or histopathology assays (IHC: Immunohistochemistry)
• Molecular assay validation experience (per FDA design control &ISO regulation) a plus
• Coordinate with laboratory management to schedule projects as per the study protocol and study schedule.

• Ph.D. in scientific area with expertise in histology (IHC ISH FISH) and/or molecular; Board certification in scientific area of expertise preferred
• 3-4 years post-doctoral or industry experience within scientific area of expertise. Additional relevant experience may be substituted for education requirements below.
• Highly skilled in conducting research data interpretation and authoring reports.
• Experience performing scientific presentations and design/development of molecular assays and/or histopathology assays (IHC: Immunohistochemistry)
• Knowledge of clinical laboratory automation system software Microsoft applications and laboratory statistics.
• Experience working in a regulated environment preferred (GCP CAP CLIA)
• Effective communication skills with technical staff business development staff peers and clients.
• Mindfulness and interpretation of scientific data.
• Demonstrated problem prevention detection and resolution.

Preferred Work Experience

• Design and development of molecular assays and/or histopathology assays (IHC: Immunohistochemistry)
• Molecular assay validation experience (per FDA design control &ISO regulation) a plus
• Coordinate with laboratory management to schedule projects as per the study protocol and study schedule

Get to know Labcorp

At Labcorp we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities we provide insights and accelerate innovations that not only empower patients and providers but help medical biotech and pharmaceutical companies transform ideas into innovations.

Here you can join our more than 60000 employees serving clients in more than one hundred countries as we work together to make a real impact on peoples lives.

Pay Range: $130000 - $150000

All job offers will bebased on a candidates skills and prior relevant experience applicabledegrees/certificationsas well as internal equity and market data.

Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical Dental Vision Life STD/LTD 401(k) Paid Time Off (PTO) or Flexible Time Off (FTO) Tuition Reimbursement and Employee Stock Purchase Plan. Casual PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan more detailed information pleaseclick here.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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