Job Description

The Senior Post Approval Monitor/Consultant will be responsible for supporting the manager in development and leading the post-approval monitoring visits across multiple regional IRBs. This role ensures adherence to regulatory requirements, ethical standards, and institutional policies through routine monitoring, for-cause auditing, and risk-based monitoring strategies. The Senior Post Approval Monitor/Consultant will support local IRB processes via annual site assist visits and conduct study-specific monitoring to maintain the highest levels of research compliance. Job Summary: This individual contributor is primarily responsible for conducting company compliance activities in collaboration with internal and external stakeholders. Responsibilities include developing compliance reports, conducting compliance investigations, coordinating implementation of compliance efforts, and assisting with regulatory compliance through monitoring regulatory changes. This individual contributor also assists with and supports management of projects including assisting in development and coordination of plans and coordinating with stakeholders. Essential Responsibilities: + Practices self-development and promotes learning in others by proactively providing information, resources, advice, and expertise with coworkers and customers; building relationships with cross-functional stakeholders; influencing others through technical explanations and examples; adapting to competing demands and new responsibilities; listening and responding to, seeking, and addressing performance feedback; providing feedback to others; creating and executing plans to capitalize on strengths and develop weaknesses; supporting team collaboration; and adapting to and learning from change, difficulties, and feedback. + Completes work assignments and supports business-specific projects by applying expertise in subject area; supporting the development of work plans to meet business priorities and deadlines; ensuring team follows all procedures and policies; coordinating resources to accomplish priorities and deadlines; collaborating cross-functionally to make effective business decisions; solving complex problems; escalating high priority issues or risks as appropriate; and recognizing and capitalizing on improvement opportunities. + Conducts company compliance activities by collaborating with internal and external stakeholders; applying established regulations and standards to compliance efforts; providing insight and recommendations for the design, development, and execution of strategic compliance initiatives; and documenting compliance activities. + Develops compliance reports by evaluating and summarizing compliance data, audit information, and potential risks and remedies; reporting to management on key compliance drivers, liabilities, and performance indicators (for example, adherence to standards, incorporation of new regulations); and developing draft presentations to convey key findings. + Conducts compliance investigations by collecting and analyzing quantitative and qualitative data; conducting interviews as appropriate; researching key business issues; identifying potential action steps; and providing input for the creation of corrective action plans for substantiated allegations. + Assists with and supports the management of projects or compliance components of larger cross-functional projects by coordinating stakeholder contacts; recommending team resources based on project needs and team member strengths; assisting in the development, analysis, and management of project plans; and coordinating project schedules and resource forecasts. + Assists with ensuring regulatory compliance by monitoring regulatory changes; conducting analysis on regulatory impacts; and supporting the implementation of designated changes. + Coordinates the implementation of compliance efforts by identifying compliance requirements; assessing the current state of compliance to identify gaps and corrective actions; creating or revising moderately complex compliance standards, policies and procedures, and training; and monitoring ongoing compliance adherence. Minimum Qualifications: + Bachelors degree in Health Care Administration, Clinical, Law, Public Health, Business or related field and Minimum six (6) years experience in compliance, health care operations (quality, risk, etc.), audit, finance, regulatory or public policy development, investigations, information security, or insurance/health plan governance or a directly related field. Additional equivalent work experience in a directly related field may be substituted for the degree requirement. Additional Requirements: COMPANY: KAISER TITLE: Senior Post Approval Monitor/Consultant LOCATION: Oakland, California REQNUMBER: 1339781 External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.

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