Clinical Reference Laboratory

Certifying Scientist

Clinical Reference Laboratory  •  Lenexa, KS (Onsite)  •  4 months ago
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Job Description

GENERAL STATEMENT OF RESPONSIBILITY: Review and interpret screening and confirmation results for donor specimens to ensure accuracy and forensic defensibility of results, and work towards a team goal of timely release of result reports.

ESSENTIAL FUNCTIONS:
Level 1 – DOT and Non-Regulated Screening
• Review and process screening batches including,
o Review of chain of custody.
o Review of screening batch data for error flags and acceptability.
o Review and complete Custody and Control forms for negative and negative dilute samples.
o Organize data and file for storage/further review.
• Recognize the importance of turnaround time and work toward the timely release of specimens.
• Interface cooperatively and clearly with all departments to direct corrective action in the event of a batch failure, incomplete/improper chain of custody documentation, computer problems related to the reporting of results, etc.
• Answer incoming phone calls/emails and assist clients and Medical Review Officers regarding the status and analysis of results.
• Communicate clearly as an “expert” when called upon to explain any/all aspects of accessioning, screening, review of screening and/or LC/MS/MS data, etc., by an inspector or in the event of a legal challenge.
• Maintain and protect the confidentiality of all CRL, CRL subsidiaries, legal entities and client information.
• Be able to comply with all applicable federal, state, and local safety and health regulations that would apply to this job.
• Keep work area neat and clean.
Other duties as assigned.

Level 2 – DOT and Non-Regulated SVT
• Review and process Specimen Validity Testing (SVT) results including:
• Review of chain of custody.
• Review and interpretation of SVT data.
• Request follow up testing as appropriate.
• Completion of Custody and Control forms for negative, negative dilute, invalid, adulterated, and substituted DOT samples.
• Organize data and file for further review and storage.

Level 3 – Non-Regulated Confirmation
• Review LC-MS/MS data for Non-Regulated confirmation batches including:
• Review of chain of custody.
• Review of raw data for acceptability.
• Review and certification of results.
• Release of samples with completed testing.

Level 4 – Regulated Confirmation
• Review all batches associated with a donor sample before release including screening, LC-MS/MS, and SVT batches.
• Review and completion of Custody and Control forms for completed specimens.

Level 5 – Hair Screening and Confirmation
• Perform screening certification and confirmation certification procedures for Hair Lab specimens

The order in which each level may be achieved is determined according to business needs, certifications, and experience and is not necessarily progressive.”

JOB QUALIFICATIONS:

EDUCATION: A doctoral, master’s, bachelor’s, or associate degree in medical technology, clinical laboratory, chemical, or biological science.

EXPERIENCE:

  • High Complexity Testing:
    Bachelor’s Degree or higher: training/experience as specified in 42CFR493.1489

Acting Technical Supervisor: Education: Bachelor’s degree in a chemical or biological or clinical laboratory science, or medical technology from an accredited institution or equivalent. Experience: 4 years of pertinent laboratory experience.

  • Prior experience as a certifying scientist highly desirable; LC/MS experience highly desirable; experience with screening operations highly desirable; experience with automated analyzers desirable.

SKILLS & ABILITIES:
• Familiarity with PC
• Must be able to read, understand, and develop strong working knowledge of appropriate SOP’s and other relevant information services
• Detail oriented; strong analytical and organizational skills
• Good communication skills; ability to work under pressure
• Ability to be at work and on time
• Ability and judgment to interact and communicate appropriately with other employees, clients and management

PHYSICAL REQUIREMENTS: The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be available to enable qualified individuals with disabilities to perform the essential functions.

The following physical attributes are required for this position:
• Sitting for extended lengths of time
• Close vision requirements due to computer work
• Repetitive use of hands, fingers, wrists, and elbows for operating a computer and telephone
• Light lifting, up to 10 pounds
• The ability to discriminate between different colors visually is considered an essential function for the position.

EQUIPMENT: PC, calculator

OTHER: Overtime, weekends, nights as required.

The employer shall, in its discretion, modify or adjust this position to meet the company’s changing needs.

This job description is not a contract and may be adjusted as deemed appropriate in the employer’s sole discretion.

• denotes essential job function.

An Equal Opportunity Employer

Pay Range: $24.00 - $43.00

Benefits for Full Time Employees:

  • Medical, Dental, Vision
  • Life/AD&D
  • Supplemental Life/AD&D
  • Section 125 FSA Plan
  • 401(k)
  • Short and Long-Term Disability
  • Paid Time Off
  • Holidays
  • Tuition Reimbursement
Clinical Reference Laboratory

About Clinical Reference Laboratory

CRL was originally founded as Enzyme Technologies in 1979 with our focus on clinical research and development. The name was changed to Clinical Reference Laboratory in 1983 when we began to offer commercial lab testing. Today, CRL has become one of the largest privately held clinical testing laboratories in the U.S., performing hundreds of thousands of tests every day for clients large and small. Our staff works around-the-clock to process and report results seven days a week.

We are driven each day to provide the useful insights people need to live healthy, safe, and productive lives. We serve insurers, employers, healthcare providers and their patients, colleges and universities, as well as federal, state, and local government agencies through a broad array of corporate and personal wellness programs, drugs of abuse testing programs, insurance risk assessment, and molecular diagnostics testing.

Together with FormFox, the nation’s leading provider of ECCF and electronic workflow solutions, we provide integrated solutions for workplace drugs of abuse testing, occupational health testing, and clinical lab testing services. CRL’s industry-leading turnaround times and state-of-the-art equipment and technology, paired with FormFox’s data management and digital workflow solutions, seamlessly connect all participants.

Our mission isn’t to be the most recognized lab, but to be the most trusted laboratory partner by providing personalized service, accurate testing, rapid turnaround time, and innovative systems and solutions. We conduct research, advance our test menu, pursue collaborations, discover new applications for existing data, and hold ourselves to the highest level of quality and client support standards, uniquely positioning our partners to achieve the best possible outcomes. And we do it all with a human touch.

Industry
Healthcare & Social Services
Company Size
201-500 employees
Headquarters
Unknown
Year Founded
1979
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