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Medical Dir Anatomic/Clinical Pathologist Hematopath Raleigh, NC asp

ESR Healthcare
Raleigh, North Carolina, United States
April 12, 2019


Medical Dir Anatomic/Clinical Pathologist Hematopath Raleigh, NC asp

Medical Director (Anatomic/Clinical Path and Hematopathologist)

Join a team who believes their employees are key to delivering on our promise and fulfilling their mission in the marketplace!


• Health Insurance & Dental Plan

• Life and Disability Insurance


• Other paid exception time includes: holiday, floater holiday, and paid sick time

• 401K Plan

• Flexible Spending Accounts

• Competitive compensation

• Innovative Environment to work with State of the Art Equipment

Job Description

Medical Director (Anatomic/Clinical and Hematopathologist)

Job Responsibilities

Position Title: Medical Director

Shift: Full Time

Location: Raleigh/Durham, NC Area

The Clinical Trial Medical and Laboratory Director is responsible for delivering quality diagnostic work, interacting with clients and overseeing clinical laboratory operations and quality processes to ensure the laboratory is following appropriate regulatory guidelines. This role regularly works with Operations, Scientific Development, and Quality Assurance to aid in increasing and maintaining a high integrity patient data.

Additional responsibilities of the Medical Director includes:

• Perform interpretation and sign out of Clinical Trial diagnostic cases, Immunohistochemical and Molecular studies including Next Generation Sequencing tests

• Issue Summation reports, compiling all available clinical and laboratory data for a specific sample into one comprehensive report with clinical interpretation.

• Assume active role in development of new, innovative assays.

• Activities include budget planning, proposal writing, liaison building with vendors, comparing informatics platforms, acquiring appropriate clinical specimens, planning workflows

• Contribute as part of a cross-functional team to the clinical development strategy, including the clinical development plans and operational plans for various malignancies.

• Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care.

• Ensure facility is following and/or implementing the most recent guidelines from regulatory agencies such as CAP, FDA, and CLIA (from multiple states).

• Ensure laboratory personnel are performing test methods as required for accurate and reliable results.

• Ensure the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and proficiency testing samples are tested as required.

• Ensure that if an approved HHS program is not available that an alternate proficiency assessment is conducted every six months.

• Ensure the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.

• Ensure all necessary remedial actions are taken and documented whenever significant deviations/CAPAs from the laboratory’s established performance characteristics are identified and that test results are reported only when the system is functioning properly.

• Ensure prior to testing specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated they can perform all testing operations reliably to provide and report accurate results.

• Ensure the performance of all testing personnel is evaluated and documented.

• Ensure testing systems in the laboratory provide quality services in all aspects of test performance (i.e. preanalytic, analytic, and postanalytic phases).

• Ensure physical and environmental conditions of the laboratory are adequate and appropriate for the testing performed.

• Ensure the environment for employees is safe from physical, chemical, and biological hazards and safety and biohazard requirements are followed.

• Monitor processes continuously to improve efficiency while maintaining quality.

• Work with Scientific Affairs to examine new methodologies in tests procedures.

• Provide consultations about medical significance of clinical laboratory data. Interpret, correlate, and communicate laboratory data to clinical requestors.

• Contribute as part of a cross-functional team to the clinical development strategy, including the clinical development plans and operational plans for various malignancies.

Medical Director (Anatomic/Clinical Pathologist and Hematopathologist)

Job Requirements

Successful candidates for the Medical Director role must have a Medical Degree (MD). Someone with board certification in Anatomic and Clinical Pathology and/or Hematopathology would be a good fit for this role.

Additional requirements of the Medical Director role include:

• Required education: Medical doctor (MD/DO)

• Current License to practice in the state of North Carolina

• Must qualify as laboratory director as promulgated by CLIA standard laboratory director qualifications

• At least 5 years of industry experience as a medical director in a laboratory environment with an oncology focus

• Excellent professional communication skills, including verbal, written and presentation

• Excellent collaboration skills, with the ability to positively influence others

• Strong leadership skills; able to support and demonstrate company mission and perform as a team members and leader

• Strong strategic and proactive thinking skills; able to make and support decisions

• Strong scientific and analytical skills

• Computer profifient with multiple software programs, including MS office suite, and laboratory management systems

Medical Director (Anatomic/Clinical Pathologist and Hematopathologist)