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Sr. Research Compliance - Post Approval Monitor/Manager

Primary Location Oakland, California Worker Location Remote Job Number 1311713 Date posted 10/09/2024
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Description:
Senior Post Approval Monitor/Manager



The Senior Post Approval Monitor/Manager will be responsible for supporting the development and leading the post-approval monitoring program 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/Manager 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 senior manager level position is primarily responsible for managing company compliance activities in partnership with internal and external stakeholders and managing strategic compliance initiatives. Responsibilities include managing compliance reporting efforts, compliance investigation, and activities associated with continued regulatory compliance across one or more business functions. Additional key responsibilities include managing the implementation of compliance efforts through monitoring, interpreting, and designing strategy around regulatory changes. This managing level employee also manages projects or compliance components of larger cross-functional projects including identifying and managing stakeholders.



Essential Responsibilities:


  • Pursues professional growth and provides developmental opportunities for others by soliciting and acting on performance feedback; building collaborative, cross-functional relationships; hiring, training, and developing talent for growth opportunities; delegating tasks and decisions; fostering open dialogue amongst departments; strategically evaluating talent for succession planning; setting performance management guidelines and expectations across units; and working closely with employees to set goals and provide open feedback and coaching to drive performance improvement.

  • Manages designated units by translating business plans into tactical action items; communicating goals and objectives; ensuring all policies and procedures are followed; overseeing the completion of work assignments; assuming responsibility for decision making; aligning team efforts; building accountability for and measuring progress in achieving results; incorporating resources, costs, and forecasts into unit plans; removing obstacles that impact performance; guiding performance and developing contingency plans accordingly; partnering with key stakeholders and business leaders to ensure products and/or services meet requirements and expectations while aligning with departmental strategies; and influencing units to operate in alignment with business objectives.

  • Manages company compliance activities by partnering with internal and external stakeholders; applying established regulations and standards to compliance efforts; managing the design, development, and execution of strategic compliance initiatives; overseeing the analysis of regulations and regulatory changes, and their application to operations; and overseeing the documentation of compliance activities.

  • Manages compliance reporting efforts across one or more business functions by managing the evaluation and summary of compliance data, audit information, and potential risks and remedies; identifying and reporting key compliance drivers, liabilities, and performance indicators (for example, adherence to standards, incorporation of new regulations) to senior management; and developing complex presentations to convey key findings to leadership and external business stakeholders.

  • Manages compliance investigations across one or more business functions by managing the collection and analysis of quantitative and qualitative data; leading interviews as appropriate; researching key business issues; and evaluating and recommending corrective action plans for substantiated allegations.

  • Manages projects or compliance components of larger cross-functional projects by identifying and managing stakeholder contacts; assembling teams based on project needs and team member strengths; developing, analyzing, and managing project plans; negotiating and managing project schedules and resource forecasts; and managing project financials and deliverables.

  • Manages activities associated with continued regulatory compliance for one or more business functions by monitoring, interpreting, and designing strategy around regulatory changes; determining the impact of changes to the business; providing direction on implementation of changes throughout the organization; and providing regulatory input before and during inspections to minimize the risks of future non-compliance.

  • Manages the implementation of compliance efforts by approving compliance requirements; ensuring the assessment of current state compliance to identify gaps and corrective actions; managing the analysis and development of complex compliance standards, policies and procedures, and training; and ensuring and monitoring ongoing compliance adherence.

Minimum Qualifications:


  • Minimum three (3) years experience in a leadership role with or without direct reports.

  • Bachelors degree in Health Care Administration, Clinical, Law, Public Health, Business or related field and Minimum eight (8) 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:
Preferred Qualifications:
  • Five (5) years experience in compliance.
  • Two (2) years supervisory experience.
  • Master’s degree in a related field (e.g., Clinical Research, Regulatory Affairs, Ethics, or similar).
  • Significant experience (5+ years) working with Institutional Review Boards (IRBs), including post-approval monitoring and follow-up on IRB requests.
  • Expertise in risk-based monitoring strategies, routine monitoring, and for-cause auditing.
  • Demonstrated experience in overseeing research compliance programs.
  • Strong knowledge of federal regulations governing human subject research (e.g., FDA, OHRP, DoD, DOJ).
  • Excellent communication and leadership skills, with a track record of building effective teams and working relationships.
  • Experience with research in diverse settings (academic, clinical, and/or industry).
Primary Location: California,Oakland,Ordway Scheduled Weekly Hours: 40 Shift: Day Workdays: Mon, Tue, Wed, Thu, Fri Working Hours Start: 08:00 AM Working Hours End: 05:00 PM Job Schedule: Full-time Job Type: Standard Worker Location: Remote Employee Status: Regular Employee Group/Union Affiliation: NUE-PO-01|NUE|Non Union Employee Job Level: Manager with Direct Reports Specialty: Compliance General Department: Po/Ho Corp - Kaiser Fdn Research Inst. - 0308 Pay Range: $162900 - $210760 / year Kaiser Permanente strives to offer a market competitive total rewards package and is committed to pay equity and transparency. The posted pay range is based on possible base salaries for the role and does not reflect the full value of our total rewards package. Actual base pay determined at offer will be based on labor market data and a candidate's years of relevant work experience, education, certifications, skills, and geographic location. Travel: No Remote: Work location is the remote workplace (from home) within KP authorized states. Worker location must align with Kaiser Permanente's Authorized States policy. At Kaiser Permanente, equity, inclusion and diversity are inextricably linked to our mission, and we aim to make it a part of everything we do. We know that having a diverse and inclusive workforce makes Kaiser Permanente a better place to receive health care, a more supportive partner in our communities we serve, and a more fulfilling place to work. Working at Kaiser Permanente means that you agree to and abide by our commitment to equity and our expectation that we all work together to create an inclusive work environment focused on a sense of belonging and wellbeing.

Kaiser Permanente is an equal opportunity employer committed to a diverse and inclusive workforce. Applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), age, sexual orientation, national origin, marital status, parental status, ancestry, disability, gender identity, veteran status, genetic information, other distinguishing characteristics of diversity and inclusion, or any other protected status. Submit Interest