The Clinical Laboratory Scientist (CLS) performs testing in the CLIA-certified laboratory, participates in quality control, quality assurance and troubleshooting activities. 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 III is expected to plan and organize his or her own work, determining work methods and assisting in the determination of priorities and deadlines. Completed work is reviewed by the CLM or designee to verify the achievement of expected results.
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 inservice and competency testing of employees.
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.
Held California Clinical Laboratory Scientist (CLS) license
BS/BA in a biology-related science
At least 6 years of experience performing high-complexity testing in a clinical laboratory for CLS III
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 proficiency in the performance of molecular testing techniques (PCR, real-time PCR, etc.) is highly desirable
Experience in immunology, microbiology or related fields is preferred
Demonstrated understanding of a disease with complex treatment algorithms highly desired
Internal Number: 1
CareDx, Inc., headquartered in Brisbane, California, is a global molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients. CareDx offers AlloMap®, a gene expression test that aids clinicians in identifying heart transplant patients with stable graft function who have a low probability of moderate to severe acute cellular rejection. CareDx is developing additional products for transplant monitoring using a variety of technologies, including AlloSure®, a proprietary next-generation sequencing–based test to detect donor-derived cell-free DNA after transplantation.
CareDx, with its presence through Olerup, also develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Olerup SSP® is a set of HLA typing used prior to hematopoietic stem cell/bone marrow transplantation and organ transplantation. XM-ONE® is the first standardized test that quickly identifies a patient’s antigens against HLA Class I, Class II or antibodies against a donor’s endothelium.
For more information, please visit: www.CareDx.com.