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
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
Ensure the establishment and maintenance of acceptable levels of
analytical performance for each test system and documenting
significant deviations from the laboratory’s established
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
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
Perform diagnostic testing according to established SOPs.
Ensure the laboratory is enrolled in an HHS approved proficiency
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
ABB (American Board of Bioanalysis)
ABCC (American Board of Clinical Chemistry in Molecular
ABMGG (American Board of Medical Genetics and Genomics)
ABBHI (American Board of Histocompatibility and
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.
Ability to work with others to plan and carry out scientific
Self-driven and works well in an interdisciplinary team with
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
9977 95th Street, Suite 101
Scottsdale, AZ 85258
460 Totten Pond Rd, Ste 420
Waltham, MA 02451-1991