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Lab Director

Company: Imperatrix Datum Solutions Corporation
Location: Scottsdale
Posted on: September 13, 2020

Job Description:

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO) that also provides comprehensive Site Management Organization (SMO) services. We are based in Scottsdale, Arizona, with an office in Waltham, Massachusetts and are an affiliate of HonorHealth, one of the largest healthcare systems nationally. Additionally, IE is an affiliate of Southwest Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the U.S. We operate in over thirty countries globally and are recognized as the preeminent iCRO for complex trials, and one of the world’s largest iCROs in oncology. We are in search of an individual who can plan, direct and coordinate the operational activities of a new laboratory of moderate complexity located in Scottsdale, AZ.

ESSENTIAL JOB FUNCTIONS

Serve as Laboratory Director of our CLIA licensed laboratory.

Consult, plan, direct, and coordinate the operational activities of a new clinical laboratory to support the infectious disease workflow with rapid turnaround times.

Establish and maintain a quality control and quality assessment program to ensure services provided are efficient and identify any failures in quality.

Provide laboratory services for all aspects of test performance and workflow, which includes pre-analytic, analytic and post-analytic phases of testing.

Develop and implement workflows for new assays.

Validate new and existing assays to determine the accuracy, precision and other pertinent performance characteristics of the method.

Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system and documenting significant deviations from the laboratory’s established performance.

Resolve technical, instrument, or unexpected test results and ensure corrective actions are taken.

Oversee safety within the laboratory and ensure all safety protocols are followed to provide a safe environment in which employees are protected from physical, chemical and biological hazards.

Maintain regulatory compliance within the lab, including COLA, CLIA, OSHA, etc.

Keep standard operating procedures up to date.

Provide technical direction, mentoring, and professional guidance to laboratory employees.

Evaluate the competency of all testing personnel on an ongoing basis.

Perform diagnostic testing according to established SOPs.

Ensure the laboratory is enrolled in an HHS approved proficiency testing program.

Must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed.

Review QC results and determine the validity of results, perform follow up as needed.

Deliver regular updates to Vice President of Clinical Research to summarize laboratory performance, turnaround times, instrument downtime, productivity, and other performance metrics.

EDUCATION AND EXPERIENCE

MD, DO, or DPM with current medical license and laboratory training/experience which consists of 1-year experience supervising non-waived testing or 20 CME credit hours in laboratory practice commensurate with director responsibilities or Equivalent laboratory training obtained during medical residency OR

Doctoral degree in chemical, physical, biological or clinical laboratory science with a certification by a board approved by HHS or 1-year experience supervising non-waived testing.

Must be currently board certified in one of the following boards:

ABB (American Board of Bioanalysis)

ABCC (American Board of Clinical Chemistry in Molecular Diagnostics)

ABMGG (American Board of Medical Genetics and Genomics)

ABBHI (American Board of Histocompatibility and Immunogenetics)

ABMLI (American Board of Medical Laboratory Immunology)

ABMM (American Board of Medical Microbiology)

NRCC (National Registry of Certified Chemists)

CLIA Laboratory Management: 3 years (Required).

At least 3 years supervising others in a CLIA/COLA moderate-complexity laboratory (Preferred).

At least 3 years managing a molecular diagnostic laboratory.

Experience in infectious disease testing highly desirable.

Understands EUA (Emergency Use Authorization) regulations.

Must have a current Arizona licensure.

SKILLS

Ability to work with others to plan and carry out scientific programs.

Self-driven and works well in an interdisciplinary team with minimal direction.

PHYSICAL REQUIREMENTS

While performing the essential duties of this position, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects; reach with hands and arms and talk and hear. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Imaging Endpoints is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

9977 N. 90th Street, Suite 300

Scottsdale, AZ 85258

Phone 480.314.3070

Fax 480.314.3080

9977 95th Street, Suite 101

Scottsdale, AZ 85258

Phone 480.314.3070

Fax 480.314.3080

460 Totten Pond Rd, Ste 420

Waltham, MA 02451-1991

Phone 480.314.3070

Fax 480.314.3080

Keywords: Imperatrix Datum Solutions Corporation, Scottsdale , Lab Director, Other , Scottsdale, Arizona

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