Clinical Risk and Regulatory Specialist

JOB SUMMARY:

The Clinical Risk & Regulatory Specialist serves as the organization's primary clinical investigator, safety strategist, and High Reliability (HRO) architect. This role transitions the facility from reactive incident review to proactive harm prevention. You will own the full lifecycle of clinical events from real-time identification and weekly rapid-response reviews to the long-term maintenance of incident reporting systems and departmental dashboards. This position requires a high level of physical presence in clinical units to ensure regulatory standards are met and that the principles of a High Reliability Organization (HRO) are embedded in daily practice. Exhibits the F.I.R.S.T. values (Friendliness, Innovation, Respect, Service, and Trust).

ESSENTIAL FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Clinical Event Leadership & Weekly Response Teams (ERRT) - 25%

• Chair the Weekly Event Review Response Team (ERRT): Lead a high-level, multidisciplinary session every week to dissect clinical incidents.

• Privileged Clinical Investigation: Conduct deep-dive reviews of EHRs and medical device data to reconstruct timelines under the Patient Safety Evaluation System (PSES) to maintain protection under the PSQIA.

• Evidence Preservation & Peer Review: Secure witness statements and physical evidence immediately following a "Hot" event; ensure findings are channeled through the Peer Review committees to invoke state-specific non-discovery statutes.

• Root Cause Analysis (RCA): Lead formal RCA and FMEA processes. Distinguish between Patient Safety Work Product (PSWP)—which is privileged—and the discoverable medical record.

• Rapid Response Risk Consultation: Serve as the primary on-call contact for "Hot" events. Provide guidance on disclosure in accordance with state "Apology Laws."

Just Culture System Oversight & Advocacy | 15%

• Algorithm Application: Act as the organizational lead in applying a recognized Just Culture Algorithm (e.g., Outcome Ingenuity or David Marx model) to all clinical errors.

• Disciplinary Audit & Oversight: Review and audit HR disciplinary actions related to clinical events to ensure a clear distinction between Human Error (console), At-Risk Behavior (coach), and Reckless Conduct (punish).

• Leadership Coaching: Provide "Just Culture" coaching to Nurse Managers and Directors to prevent "blame-and-shame" responses and ensure that system-driven errors do not result in individual sanctions.

• Safety Culture Reporting: Analyze and report on "Safety Culture Surveys," specifically tracking staff perception of the non-punitive response to error.

Clinical Risk Education & Curriculum Development - 15%

• Continuum-Wide Education: Design, implement, and lead clinical risk and safety education programs across the entire continuum of care (Inpatient, Ambulatory, and Ancillary services).

• Report Management Education: Train Department Directors and frontline staff on effective report management, including how to draft objective incident descriptions that avoid speculative or inflammatory language.

• Report Management Operations: Mapping configuration, onboarding new users and areas, and proactive monitoring of events to ensure data integrity and operational efficiency.

• Closing the Loop: Manage the follow-up educational process; ensure that "lessons learned" from RCAs and near-misses are translated into staff huddle guides, newsletters, or training sessions.

• Onboarding & Competency: Own the Risk/Regulatory portion of new-hire orientation and annual clinical competencies, focusing on regulatory readiness and HRO behaviors.

Clinical Rounding, HRO Vigilance, & Presence - 15%

• High-Intensity Clinical Rounding: Spend a minimum of 30% of the work week "on the floor." This requires prolonged walking and standing across all campus departments.

• Strategic HRO Collaboration: Work directly with the Patient Safety Officer (PSO) and Nursing Excellence Coordinator to design and implement a unified HRO integration strategy.

• Real-Time Tracer Methodology: Conduct unannounced tracers and interview staff on high-risk protocols (e.g., "Time Outs" or "Hand-offs").

• Workplace Violence Prevention: Work with the workplace violence coordinator to review all incidents with the same rigor as clinical errors while collaborating with the Patient Safety Officer, Security and Behavioral Health Associates.

Dashboard Advocacy & Data Governance - 5%

• Departmental Measurement Selection: Act as the "Dashboard Champion," assisting select Department Directors in identifying High-Volume, High-Risk, or Problem-Prone metrics.

• Formatting & Visualization: Design and maintain department-specific safety dashboards to clearly show trends and benchmarks.

• Question Management: Oversee the integrity of data collection tools; refine audit questions to eliminate bias.

Predictive Risk Identification & Quality Coordination - 10%

• Advanced "Trigger" Surveillance: Design and manage automated surveillance to identify harm before a manual report is filed (e.g., Narcan use, unplanned ICU transfers).

• QI Integration: Serve as the bridge between Risk and Quality Improvement (QI) by transitioning predictive trends into formal Performance Improvement Projects (PIPs).

• Advanced Technology Oversight: Audit the clinical risk profiles of AI-driven decision support tools (e.g., sepsis predictors) and Virtual Nursing/Telehealth workflows to ensure they meet safety standards.

Medical Staff & Director Collaboration - 10%

• Process Improvement Partnerships: Work directly with Medical Staff Leadership and Nursing Directors to re-engineer failing clinical processes.

• Regulatory Advocacy: Act as a consultant to Department Directors during policy-review cycles to ensure clinical resources align with CMS safety mandates.

Complaint Management & Patient Relations - 5%

• Clinical Grievance Review: Partner with Patient Experience to investigate clinical grievances within CMS mandated timeframes (7–30 days).

• Legal Stewardship: Ensure grievance responses are empathetic yet factually precise, avoiding language that could be construed as a legal admission of negligence.

WORKING CONDITIONS, HAZARDS AND PHYSICAL EFFORT:

High Mobility: This is not a sedentary desk job. The role requires prolonged walking (up to 3–5 miles per shift) and standing while navigating various clinical units, stairwells, and campus buildings for rounds and tracers.

CONTACTS WITH OTHERS:

Patients, family members and significant others, physicians and Associates, other healthcare providers, community resource personnel, administrative staff, and hospital support services.

EQUIPMENT USED/SPECIAL SKILLS REQUIRED:

Demonstrated experience with HRO principles, Just Culture frameworks, Lean Six Sigma and PSQIA privilege protections. Mastery of Risk Management (RM) software (e.g., RLDatix) and advanced Excel/Data Visualization skills.

5–7 years of acute care clinical experience, with at least 3 years in a dedicated Healthcare Risk Management, Patient Safety, or Regulatory Compliance role.