Clinical Laboratory Scientist

March 28, 2024

Job Description

Company Description
CareDx, Inc., based in Brisbane, California, is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value, non-invasive diagnostic surveillance solutions for transplant recipients. The Company has commercialized AlloMap, a gene expression test that aids clinicians in identifying heart transplant… recipients with stable graft function who have a low probability of moderate/severe acute cellular rejection. CareDx is also pursuing the development of additional products for post-transplant monitoring of other solid organs that use a variety of technologies, including next-generation sequencing, to detect donor-derived cell-free DNA to monitor the health of organs after transplantation. For more information, please visit: www.CareDx.com.

Job Description

Specifications

Title: Clinical Laboratory Scientist

Manager: Clinical Laboratory Manager

FLSA: Non-Exempt

Classification: Regular Full Time

Department: Reference Lab

Location: Brisbane, CA

Management: N/A

Schedule: 1pm – 9:30pm, Tuesday – Saturday. Schedule may change and rotate.

General Description

The Clinical Laboratory Scientist (CLS) performs testing in the CLIA-certified CareDx Reference laboratory, participates in quality control, quality assurance and troubleshooting activities, and leads testing for special research and development studies.

A CLS performs duties under general direction, carrying out work assignments in accordance with policies and objectives established by the Clinical Laboratory Manager (CLM) or designee. A CLS is expected to plan and organize his or her own work, determining work methods and assisting in the determination of priorities and deadlines. A CLS is responsible for the proficient performance of his or her own work assignments. Completed work is reviewed by the CLM or designee to verify the achievement of expected results.

A CLS is responsible for the proficient performance of his or her own work assignments and is expected to provide guidance to less-experienced personnel in the Reference Laboratory and other groups.

Responsibilities include, but not necessarily limited to:

The Clinical Laboratory Scientist (CLS) performs testing in the CLIA-certified CareDx Reference laboratory, participates in quality control, quality assurance and troubleshooting activities, and leads testing for special research and development studies.

A CLS performs duties under general direction, carrying out work assignments in accordance with policies and objectives established by the Clinical Laboratory Manager (CLM) or designee. A CLS is expected to plan and organize his or her own work, determining work methods and assisting in the determination of priorities and deadlines. A CLS is responsible for the proficient performance of his or her own work assignments. Completed work is reviewed by the CLM or designee to verify the achievement of expected results.

A CLS is responsible for the proficient performance of his or her own work assignments and is expected to provide guidance to less-experienced personnel in the Reference Laboratory and other groups.

Responsibilities include, but not necessarily limited to:

Handle and process patient samples, analyze test results, prepare reports and maintain records of test results.

May be required to accession samples into the laboratory information management system (LIMS) to facilitate sample throughput.

Comply with CareDx quality control policies and document QC activities including instrument and procedural calibrations and maintenance.

Maintain confidentiality of personal health information (PHI).

Identify problems that may affect test performance or results and, following established protocols, correct problems or escalate to Clinical Laboratory Manager, technical supervisor, clinical consultant or lab director.

Identify test systems that deviate from acceptable performance specifications and follow established policies and procedures to correct operation.

Document corrective actions taken when test systems deviate from established performance specifications.

Teach/train CareDx policy, methods and techniques to new employees; may perform in-service and competency testing of employees.

Participate in development and validation of new, complex assays and technology transfer and interactions with other groups.

Participate in drafting and developing standard operating procedures for tasks in which proficiency has been demonstrated.

Represent the Reference lab testing, quality control and quality assurance program in interactions with other groups.

Under direction of the CLM, investigate and follow-up on proficiency testing, quality control results and patient testing that does not meet standards.

Perform additional duties and projects assigned by the Clinical Laboratory Manager.

Demonstrate knowledge of, and support, the CareDx mission, vision, value statements, standards, policies and procedures, operating instructions, confidentiality standards, and ethical behavior.

Comply with all local, state, and federal laws and regulations governing clinical laboratory operations.

Additional duties and responsibilities:

May perform phlebotomy duties as needed.

Accountability and measures:

Must be able to consistently complete testing of a standard batch of samples within established time frames

Review and follow up incomplete testing as needed.

Must be able to consistently complete testing without repeats due to technical errors at levels established by annual performance or laboratory goals.

Must be able to perform quality control testing, analyze data and prepare reports for management review within established time frames.

Qualifications

Held California Clinical Laboratory Scientist (CLS) license for over 3 year preferred
-Acceptable licenses include Clinical Laboratory Scientist (Generalist), Clinical Chemist Scientist, Clinical Microbiologist Scientist, and Clinical Genetics Molecular Biologist Scientist
BS/BA in a biology-related science
Demonstrated proficiency in the performance of molecular testing techniques (PCR, real-time PCR, etc.) highly desirable
Experience in immunology, microbiology or related fields preferred
2+ years experience performing high-complexity testing in a clinical laboratory
Proficiency in Microsoft Office suite of programs (Outlook, Word, Excel, PowerPoint, etc.)
Demonstrated analytical skills, including working with databases and Excel
Strong interpersonal skills
Ability to build and maintain effective working relationships with CareDx employees at all levels as well as customers and vendors.
Demonstrated understanding of a disease with complex treatment algorithms
Recent phlebotomy experience desired
Ability to communicate effectively in English, verbally and in writing, within the work group

Additional Information

Work Environment:

Travel is not a primary aspect of this position although travel may be requested from time to time. An employee in this position may work in an environment, or visits facilities, in which safety, environmental and health concerns may demand constant attention. Adherence to the Corporate and/or Plant policies, rules, and regulations in these areas is required.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands and fingers, handle or feel, and talk or hear. The employee frequently is required to sit, stand and walk. There will be periods of time during the workday where you will be sitting for 3-4 hours in a row. Regular use of hands to operate office equipment and type on the keyboard will be required. The employee may occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

While working in the laboratory, incumbents may be exposed to excessive noise, chemicals and solvents, biological agents, mechanical/electrical hazards, and blood borne pathogens. Adherence to using personal protection equipment is required in the laboratories.

All your information will be kept confidential according to EEO guidelines.

CareDx is an Equal Opportunity Employer