Company:
Prima Medical Foundation dba MarinHealth Medical Network
Work Shift:
8 Hour (days) (United States of America)
Scheduled Weekly Hours:
40
Job Description Summary:
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 position functions as a subject matter expert responsible for planning, implementing, monitoring, and continuously improving programs that support regulatory compliance, patient safety, and clinical quality.
This role exercises substantial discretion and independent judgment in partnership with the clinical practice leaders in interpreting regulatory requirements, evaluating compliance risks, developing corrective action plans, and advising operational and clinical leaders regarding compliance obligations and patient safety concerns. The incumbent is authorized by the clinical practice to develop standards, policies, training programs, auditing processes, and performance improvement initiatives that impact multiple clinical sites and service lines.
The Clinical Practice Specialist works collaboratively with clinical operations, infection prevention, laboratory services, quality, risk management, and practice leadership to ensure compliance with applicable federal, state, accrediting body, and manufacturer requirements.
Job Requirements, Prerequisites and Essential Functions:
Pay Range: $36.00 - 45.00 - 54.00
Essential Functions and Responsibilities:
Regulatory Readiness & Accreditation
- Leads and coordinates ambulatory regulatory readiness activities across assigned clinics and service lines.
- Develops and maintains readiness plans, accreditation tools, tracer methodologies, mock surveys, and audit processes per guidelines as directed by clinical practice leadership.
- Conducts compliance assessments and gap analyses to identify regulatory vulnerabilities.
- Evaluates findings and independently develops corrective and preventive action plans.
- Tracks organizational readiness for regulatory surveys, inspections, and accreditation reviews.
- Serves as a resource during surveys conducted by regulatory and accrediting agencies.
- Monitors changes in regulatory requirements and proactively implements needed program modifications.
CLIA Program Administration
- Manages the operational oversight of ambulatory CLIA certificates and associated regulatory requirements.
- Coordinates CLIA applications, renewals, modifications, and supporting documentation.
- Maintains network-wide inventories of laboratory testing sites, testing complexity levels, and compliance requirements.
- Monitors quality control, quality assurance, proficiency testing, competency validation, and documentation requirements.
- Partners with laboratory leadership and clinic teams to address deficiencies and implement corrective actions.
- Develops tools and processes to promote ongoing laboratory compliance and survey readiness on behalf of the clinical practice director.
Reprocessing & High-Level Disinfection Program Oversight
- Oversees ambulatory reprocessing, sterilization, and high-level disinfection compliance programs.
- Performs audits of instrument reprocessing workflows, documentation, storage practices, biological monitoring, maintenance records, and competency programs.
- Helps to review and interpret manufacturer Instructions for Use (IFUs) and regulatory standards.
- Develops standardized workflows, policies, educational materials, and monitoring tools.
- Assesses compliance risks related to reprocessing and recommends mitigation strategies.
- Collaborates with Infection Prevention, Supply Chain, Facilities, and Operations leaders to address identified deficiencies.
- Monitors compliance with organizational standards and applicable regulatory requirements.
Clinical Practice & Patient Safety
- Conducts patient safety and regulatory risk assessments.
- Participates in investigations involving compliance concerns, process failures, and patient safety events.
- Identifies trends and develops performance improvement initiatives following guidelines established by the clinical practice team.
- Supports implementation of evidence-based clinical practice standards.
- Collaborates with operational leaders to improve consistency, standardization, and safety across practices.
- Develops recommendations to reduce organizational risk and improve compliance outcomes with guidance from clinical practice leadership.
Education & Consultation
- Develops and delivers educational programs related to reprocessing, laboratory compliance, and regulatory requirements.
- Provides consultation and guidance to clinic leaders, managers, and staff.
- Develops competency assessment tools and compliance resources.
- Serves as a subject matter expert for assigned programs.
- Facilitates ongoing regulatory readiness and compliance education.
Program Oversight & Independent Judgment
- Helps to interpret federal, state, accreditation, and organizational requirements and translate them into operational practices.
- Develops policies, procedures, standards, toolkits, audit methodologies, and compliance monitoring programs with direction from the clinical practice director and quality leadership.
- Determines priorities for audits, assessments, and follow-up activities based on risk evaluation and organizational needs.
- Exercises judgment when identifying risks, recommending process improvements, and implementing corrective actions.
- Leads multidisciplinary workgroups and compliance initiatives without direct supervisory authority.
- Makes recommendations to leadership regarding resource needs, program priorities, compliance risks, and corrective actions.
- Maintains compliance dashboards, metrics, and executive reporting.
Decision-Making Authority
The incumbent is authorized by the clinical practice director to:
- Conduct independent compliance assessments and risk analyses.
- Determine appropriate corrective and preventive actions for identified deficiencies followed by consultation with clinical practice leadership.
- Recommend temporary suspension of non-compliant reprocessing or testing practices pending remediation.
- Develop and implement compliance monitoring strategies with guidance from clinical practice leadership.
- Recommend revisions to policies, procedures, and standards.
- Escalate regulatory or patient safety concerns to leadership.
- Represent Clinical Practice & Safety during readiness activities, audits, tracers, and survey preparation initiatives.
Qualifications:
Education:
- Associate degree in: Medical Assisting, Health Sciences, Healthcare Administration, Public Health, Business Administration, Nursing, or related field.
License & Certifications:
One or more preferred:
- 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
- Project Management Certification
Experience:
- Minimum five (5) years of healthcare experience in ambulatory care, procedural services, laboratory services, infection prevention, quality, compliance, or clinical operations.
- Minimum three (3) years leading projects, programs, audits, accreditation activities, performance improvement initiatives, or compliance programs.
- Demonstrated experience working with healthcare regulations, standards, and quality processes.
- Experience supporting regulatory surveys, accreditation activities, or compliance programs preferred.
- Experience with reprocessing, sterilization, high-level disinfection, laboratory operations, or CLIA compliance preferred.
Prerequisite Skills:
- 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
Accommodation:
Qualified applicants with disabilities may request reasonable accommodation during the application process by contacting Human Resources at 415-925-7040 or TalentAcquisition@mymarinhealth.org.
C.A.R.E.S. Standards:
MarinHealth seeks candidates ready to model our C.A.R.E.S. standards—Communication, Accountability, Respect, Excellence, Safety—which foster a healing, trust-based environment for patients and colleagues.
Health & Immunizations:
To protect employees, patients, and our community, MarinHealth requires measles, mumps, varicella, and annual influenza immunizations as a condition of employment (and annually thereafter). COVID-19 vaccination/booster remains strongly recommended. Medical or religious exemptions will be considered consistent with applicable law.
Compensation:
The posted pay range complies with applicable law and reflects what we reasonably expect to pay for this role. Individual pay is set by skills, experience, qualifications, and internal/market equity, consistent with MarinHealth’s compensation philosophy. Positions covered by collective bargaining agreements are governed by those agreements.
