Clinical Practice Specialist, Clinical Operations (Novato), Full Time, Days

MarinHealth•Novato, CA

4d•$36 - $54•Onsite

About The Position

The Clinical Practice Specialist serves as the organizational lead for ambulatory reprocessing, Clinical Laboratory Improvement Amendments (CLIA) compliance, and regulatory readiness programs across the medical network. The role plans, implements, monitors, and continuously improves programs supporting regulatory compliance, patient safety, and clinical quality. Working with clinical practice leaders, the specialist exercises independent judgment to interpret regulatory requirements, assess compliance risks, develop corrective action plans, and advise operational and clinical leaders. The position develops standards, policies, training programs, audit processes, and performance improvement initiatives affecting multiple clinical sites and service lines. The specialist collaborates with clinical operations, infection prevention, laboratory services, quality, risk management, and practice leadership to support compliance with applicable federal, state, accrediting body, and manufacturer requirements. The role also supports regulatory readiness and accreditation, administers ambulatory CLIA programs, oversees reprocessing and high-level disinfection compliance, advances patient safety and clinical practice, and provides education and consultation. Regular travel between clinic locations and onsite audits and observations are required.

Requirements

Associate degree in Medical Assisting, Health Sciences, Healthcare Administration, Public Health, Business Administration, Nursing, or a related field.
Minimum of five years of healthcare experience in ambulatory care, procedural services, laboratory services, infection prevention, quality, compliance, or clinical operations.
Minimum of three years leading projects, programs, audits, accreditation activities, performance improvement initiatives, or compliance programs.
Demonstrated experience working with healthcare regulations, standards, and quality processes.
Ability to travel regularly between clinic locations.
Ability to conduct onsite audits and observations in clinical environments.
Ability to sit, stand, walk, bend, and use standard office equipment as required.
Measles, mumps, and varicella immunizations, and annual influenza immunization, are conditions of employment; medical or religious exemptions will be considered consistent with applicable law.

Nice To Haves

One or more of the following certifications: Certified Medical Assistant (CMA), Registered Medical Assistant (RMA), Certified Clinical Medical Assistant (CCMA), Certified Professional in Healthcare Quality (CPHQ), Certified Ambulatory Infection Preventionist (CAIP), Lean or Process Improvement Certification, or Project Management Certification.
Experience supporting regulatory surveys, accreditation activities, or compliance programs.
Experience with reprocessing, sterilization, high-level disinfection, laboratory operations, or CLIA compliance.

Responsibilities

Lead and coordinate ambulatory regulatory readiness activities across assigned clinics and service lines.
Develop and maintain readiness plans, accreditation tools, tracer methodologies, mock surveys, and audit processes.
Conduct compliance assessments and gap analyses; evaluate findings and develop corrective and preventive action plans.
Track readiness for regulatory surveys, inspections, and accreditation reviews, and serve as a resource during agency surveys.
Monitor regulatory changes and implement necessary program modifications.
Manage operational oversight of ambulatory CLIA certificates, including applications, renewals, modifications, and supporting documentation.
Maintain network-wide inventories of laboratory testing sites, testing complexity levels, and compliance requirements.
Monitor laboratory quality control, quality assurance, proficiency testing, competency validation, and documentation requirements.
Partner with laboratory leadership and clinic teams to address deficiencies and support ongoing laboratory compliance and survey readiness.
Oversee ambulatory reprocessing, sterilization, and high-level disinfection compliance programs.
Audit instrument reprocessing workflows, documentation, storage practices, biological monitoring, maintenance records, and competency programs.
Review and interpret manufacturer Instructions for Use and regulatory standards; develop standardized workflows, policies, educational materials, and monitoring tools.
Assess reprocessing compliance risks and collaborate with Infection Prevention, Supply Chain, Facilities, and Operations leaders to address deficiencies.
Conduct patient safety and regulatory risk assessments and participate in investigations involving compliance concerns, process failures, and patient safety events.
Identify trends and develop performance improvement initiatives; support evidence-based clinical practice standards and consistency across practices.
Develop and deliver education on reprocessing, laboratory compliance, and regulatory requirements; consult with clinic leaders, managers, and staff.
Develop competency assessment tools and compliance resources and serve as a subject matter expert for assigned programs.
Interpret regulatory, accreditation, and organizational requirements and translate them into operational practices, policies, procedures, standards, toolkits, and monitoring programs.
Prioritize audits, assessments, and follow-up based on risk and organizational needs; lead multidisciplinary workgroups and compliance initiatives without direct supervisory authority.
Maintain compliance dashboards, metrics, and executive reporting and make recommendations to leadership regarding resources, priorities, risks, and corrective actions.
Conduct independent compliance assessments and risk analyses; recommend corrective and preventive actions, policy revisions, and temporary suspension of non-compliant reprocessing or testing practices pending remediation.
Escalate regulatory or patient safety concerns and represent Clinical Practice & Safety in readiness activities, audits, tracers, and survey preparation.