Share Email Opening Title Laboratory Director - IVF  EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description Job Summary: This is a position for a PhD level embryologist with clinical experience in human Assisted Reproductive Technology (ART) or an MD with a background in embryology, andrology and endocrinology to perform administrative duties and laboratory director activities in accordance with the laboratory mission statement and regulatory agency guidelines, including but not limited to; New York State Department of Health Clinical Laboratory Evaluation Program, New York State Department of health Tissue Bank Resources Program, United States Food and Drug Administration (FDA), Clinical Laboratory Improvement Act of 1988 (CLIA ‘88), and the Centers for Disease Control (CDC) National ART Surveillance System (NASS), and the Society for Assisted Reproductive technologies (SART). Essential Job Functions: The responsibilities of the embryology laboratory director include: Formulating laboratory policies and protocols and communicating with the medical director regarding patient progress and protocols as they affect the laboratory aspects of treatment. Providing accessibility for on-site, telephone, or electronic consultations with on-site laboratory personnel as needed. Ensuring that the physical plant (space, facilities, and equipment) and environmental conditions of the laboratory are appropriate and safe. Maintaining aseptic conditions in the laboratory. Ensuring that patient confidentiality is maintained throughout the laboratory ART process. Providing all laboratory personnel unrestricted access to an approved procedural manual (print or electronic) and establishing and maintaining a laboratory quality assurance program. Providing consultation to physicians and others in the practice, as appropriate, regarding laboratory aspects of treatment. Employing a sufficient number of qualified laboratory personnel to perform the quality laboratory procedures. Ensuring that there is a personnel contingency plan in case of emergency. Ensuring that all personnel receive appropriate training for the ART laboratory procedures to be performed, obtain the required number of annual continuing education hours, and demonstrate continued competence for the ART laboratory procedures performed. Study and review Embryology Laboratory Standard Operating Procedures Manual and become familiar with quality assurance, quality control, safety procedures, and operating guidelines for performing laboratory services and ensure that protocols meet the current requirements of all regulatory agencies. Participate in laboratory operations and laboratory services Patient interaction Study and review OSHA requirements. Study and review of all regulatory agency guidelines including, but not limited to, the United States Food and Drug Administration (FDA), the New York State Department of Health (NYSDOH), the New York State Department of Health Blood and Tissue Resources Program, Clinical Laboratory Improvement Act of 1988 (CLIA ‘88), and the Centers for Disease Control (CDC) National ART Surveillance System (NASS). Annual review of Embryology Laboratory Standard Operating Procedures Manual. Overseeing all laboratory research projects. Responsible for laboratory certification, and maintenance of current certifications. Periodic review of Quality Control/Quality Assurance. Recruiting and selecting new staff. Teaching visiting students. Coaching, counseling, and disciplining employees. Act as embryology departmental liaison to the team of physicians. Initiate, coordinate, and enforce practice and operational policies and procedures. Oversee input of patient cycle information into laboratory data program, as well as into NASS via the Society of Assisted Reproductive Technology data system (SART Cors). Assist in the practice’s overall professional development by hosting journal clubs and other educational activities. Work cooperatively with a multidisciplinary team to provide quality patient care, while meeting the objectives and goals of the practice. Insure that all policies and procedures are communicated to department staff. Attend practice and department meetings as requested. Work weekends and holidays as scheduled, inclusive of beeper/on-call responsibilities.   Category Provider   Exempt/Non-Exempt Exempt   Location Commack- Reproductive Endocrinology/Fertility   Full-Time/Part-Time Full-Time   Position Requirements Have an earned doctorate degree (Ph.D.) from an accredited institution in a chemical, physical, or biological science as the major subject, or a medical degree (M.D. or D.O.) from VOL. 115 NO. 3 / MARCH 2021 579 Fertility and Sterility® an accredited institution or have qualified as a laboratory director before July 20, 1999. Effective January 1, 2006, for all new laboratory directors, hold a High-complexity Clinical Laboratory Director (H.C.L.D.) or Embryology Laboratory Director (E.L.D.) certification or its equivalent from the American Board of Bioanalysis (ABB). Laboratories that participate in high complexity procedures (i.e., quantitative sperm preparations and some hormone analyses) must be supervised by a laboratory director that is certified as an H.C.L.D. Have expertise and/or specialized training in biochemistry, cell biology, and physiology of reproduction with experience in experimental design, statistics, and problem solving. Have 2 years of documented pertinent experience in a program performing IVF-related procedures. This experience should include: Familiarity with laboratory quality control, inspection, and accreditation procedures. Detailed knowledge of cell culture, ART, and andrology procedures performed in human systems. At least 6 months of training (may be concurrent with documented experience) and completion of at least 60 ART procedures under supervision. A procedure is defined as a combination of the examination of follicular aspirates, insemination, documentation of fertilization, and preparation for embryo transfer. Satisfactory completion of this period of training should be documented by the laboratory director of the training practice. At least 24 hours of accredited continuing education every 2 years in ART or clinical laboratory practice. Demonstrated technical competence in the embryology laboratory by documenting performance of specific procedures and results that are within acceptable standards for that program. Holds and maintains a valid High-Complexity Laboratory Director (HCLD) certificate. Holds a valid certificate of qualification from NYS to direct a clinical laboratory or is a licensed pathologist with appropriate experience and certification to direct a clinical laboratory in the state of New York. Serves the laboratory full-time, or on a regular part-time basis. Regular part-time basis shall mean assumption of full responsibility for direction and technical operation of the laboratory, including adherence to the department quality control standards and training of personnel performing the testing. If he serves on a regular part-time basis, he shall not serve as director of more than two clinical laboratories, within or outside New York State or more than one clinical laboratory and one blood bank or more than two blood banks. Where a laboratory and a blood bank are on the same premises and are under the supervision of the same director, such laboratory and blood bank shall be deemed one laboratory for the purpose of this subdivision. Notwithstanding the foregoing provisions of this subdivision, if the commissioner finds that more than two laboratories are required to serve the needs of an area and the total volume and the types of laboratory service provided by the several laboratories are not such as to require the services of more than one director, he may authorize an individual to direct more than two laboratories or blood banks or combinations thereof. Such authorization must be renewed at least every two years. The commissioner may also make an exception where the additional directorships involve only blood-holding facilities as defined in section 58-2.1(i) of NYS Public Health Law Title 10 part 58. Commensurate with the laboratory workload, scope and complexity of the testing procedures carried out, qualifications of onsite personnel, proximity to another laboratory under identical directorship, and availability of alternate monitoring and communications capabilities, the director shall spend an adequate amount of time in the laboratory to direct and supervise the technical performance of the staff and shall be readily available for personal or telephone consultation. The adequacy of the amount of time a laboratory director is present and in active direction shall be determined by the department based on the factors enumerated above, results of onsite inspections and proficiency testing and documentation of the director's full responsibility for direction and technical operation. Attendance records may be required to document the adequacy of the director's presence. Responsible for performance of all tests carried out in the laboratory, adherence to the department's quality assurance standards for such tests, and accurate reporting of the test results. Responsible for ensuring the employment of qualified laboratory personnel, evaluation of job performance of such personnel and their in-service training. If the director's employment terminates or he/she is temporarily absent, arrangements shall be made for a qualified temporary director, which arrangements must receive the prior approval of the department. An assistant director who holds a certificate of qualification to be a director of a clinical laboratory or blood bank in the appropriate category may act for the director in the director's absence, and at such time shall fully discharge the duties and responsibilities of the director. When the director's employment terminates, for whatever reason, both the owner and the director of the laboratory, or the chief executive officer of the facility, shall notify the department in writing prior to the termination. In the case of death or physical and/or mental incapacitation of the director, the owner or the chief executive officer must notify the department within 72 hours of each event. Other Qualifications: Educational, Presentation and Listening Skills Working knowledge of Electronic Medical Records and other Software Clinical experience in Physician Practice Excellent communication, decision making, leadership and problem solving skills Proven ability to access, input, and retrieve information from a computer. Knowledge of office procedures and office machines (i.e. computer, fax, copier, etc.). Ability to work as part of a multidisciplinary team. Ability to work in a high standard, stressful environment. Ability to communicate accurately and concisely. Excellent interpersonal skills.   Shift Days   Tags   Salary Range   Position Laboratory Director-IVF   Open Date 5/25/2021   This position is currently not accepting applications. 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