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

MarinHealth Medical Center•Novato, CA

3d•Onsite

About The Position

The Clinical Practice Specialist serves as the organizational lead for ambulatory reprocessing, CLIA compliance, and regulatory readiness programs across MarinHealth Medical Network. The role plans, implements, monitors, and continuously improves programs supporting regulatory compliance, patient safety, and clinical quality. In partnership with clinical practice leaders, the specialist interprets regulatory requirements, evaluates compliance risks, develops corrective action plans, and advises operational and clinical leaders on compliance obligations and patient safety concerns. The specialist develops standards, policies, training programs, auditing processes, and performance improvement initiatives that affect multiple clinical sites and service lines. The role works 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. It also leads readiness activities, administers ambulatory CLIA program operations, oversees reprocessing and high-level disinfection compliance, supports patient safety and quality improvement, and provides education and consultation to clinic leaders, managers, and staff. This position exercises independent judgment in assessing risks, prioritizing audits and follow-up, recommending corrective actions and policy changes, and escalating regulatory or patient safety concerns. It may lead multidisciplinary initiatives without direct supervisory authority. The role requires regular travel between clinic locations and onsite audits and observations in clinical environments. The schedule is full time, 40 hours per week, on an 8-hour day shift.

Requirements

Associate degree in Medical Assisting, Health Sciences, Healthcare Administration, Public Health, Business Administration, Nursing, or a related field.
At least five years of healthcare experience in ambulatory care, procedural services, laboratory services, infection prevention, quality, compliance, or clinical operations.
At least 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, varicella, and annual influenza immunizations are required as a condition of employment and annually thereafter; 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; serve as a resource during surveys.
Monitor regulatory changes and implement needed program modifications.
Manage operational oversight of ambulatory CLIA certificates, including applications, renewals, modifications, and supporting documentation.
Maintain 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 corrective actions.
Oversee ambulatory reprocessing, sterilization, and high-level disinfection compliance programs.
Audit instrument reprocessing workflows, documentation, storage, biological monitoring, maintenance records, and competency programs.
Review and interpret manufacturer Instructions for Use and regulatory standards; develop standardized workflows, policies, education materials, and monitoring tools.
Assess reprocessing compliance risks and collaborate with Infection Prevention, Supply Chain, Facilities, and Operations leaders on deficiencies and mitigation.
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 consistent, safe practices.
Develop and deliver education on reprocessing, laboratory compliance, and regulatory requirements; provide consultation to clinic leaders, managers, and staff.
Develop competency assessment tools and compliance resources, and facilitate ongoing regulatory readiness education.
Translate regulatory and organizational requirements into operational practices; develop policies, procedures, standards, toolkits, audit methods, and monitoring programs with leadership direction.
Determine audit, assessment, and follow-up priorities based on risk and organizational needs; lead multidisciplinary workgroups and compliance initiatives.
Maintain compliance dashboards, metrics, and executive reporting; recommend resource needs, program priorities, and corrective actions to leadership.
Conduct independent compliance assessments and risk analyses; recommend corrective and preventive actions, temporary suspension of non-compliant reprocessing or testing practices, policy revisions, and escalation of concerns.
Represent Clinical Practice & Safety during readiness activities, audits, tracers, and survey preparation initiatives.