Program Operations Specialist

Position: Program Operations Specialist 1
Duties Description The Human Genetics Department and Specialty Clinical Laboratories (SCL) at I  work in collaboration to complete laboratory testing both for clinical purposes and to support the research protocols in place within the Human Genetics laboratories at I . We are seeking to fill a Program Operations Specialist 1 position, where the incumbent will support the program and staff of our Human Genetics (HG) Department including the Specialty Clinical Laboratories (SCL), working in conjunction with each other and with the developing Genomics Core Facility.

The individual will be supervised by the Research Group Head of the department/laboratory.

This position involves completing procedures needed for testing protocols, basic laboratory procedures, data entry, billing and compilation/tracking, assisting with cataloging and maintaining all records as per the regulatory requirements; supporting supervisor in scheduling Competency and Proficiency testing programs; and scheduling periodic and as needed maintenance on instrumentation/equipment. Staff will address the administrative/programmatic needs of the department/laboratory, handle technical/programmatic duties in the laboratory and participate in the implementation of programs and services that address the diagnostic needs of our patients with intellectual and developmental disabilities.

Ensure compliance with CLIA, CMS, and NYS DOH CLEP requirements, including maintenance of laboratory permits, inspection readiness, deficiency tracking, and corrective action documentation. Coordinate Quality Management System (QMS) activities including SOP control, document versioning, deviation tracking, and continuous audit preparedness. Serve as the primary administrative liaison to the Laboratory Director for regulatory compliance, personnel documentation, training records, and inspection coordination. Support early-stage development of the Genomics Core Facility by assisting with administrative infrastructure, documentation frameworks, regulatory alignment, and coordination of new genomic workflows as they are established.

Primary Responsibilities for the POS position in the Human Genetics/Specialty Clinical Laboratory (SCL) Division include but are not limited to:

• Individual will contribute appropriately to the implementation of new protocols and the ongoing monitoring and evaluation of existing and newly developed protocols.

• Attend to obligations including but not limited to (e.g. Department Of Health (DOH) audits for example, HIPAA, IRB (Institutional Review Board) protocols)

• Provide administrative support to departments to promote the planning, development, implementation, monitoring and ongoing evaluation of programs and services that are in place in this department/research group/laboratories. Support the needs of the SCL both programmatically (basic laboratory preparation testing procedures) and administratively (data entry, billing).

• Liaison with clinical staff to obtain, process and "send out" obtained clinical specimens (centrifuge, packaging, pickups, internal delivery). Ensure completion/delivery of specimen.

• Work with Human Genetics Department/SCL staff to obtain, enter and disseminate patient test results, ensure receipt by the indicated individual/referral source

• Be responsible for maintaining comprehensive patient database/billing interface with outside entity to ensure accurate data entry and subsequent billing for patient laboratory services

• Monitor and follow up with billing company, referral sources, individuals (private pay) to ensure billing process is completed and payment received

• Work with Laboratory Director to ensure timely preparation for scheduled and anticipated evaluations by outside auditing agencies (Department of Health, Institutional Review Board).

• Work with all lab employees to ensure licensing and all DOH requirements current and always prepared for audit/review. Support supervisor in completion of competency and proficiency testing programs.

• Be responsible for maintenance of all indicated procedure manuals, ensuring up to date and always ready for audit/review

• Be responsible to liaison with…