Job Posting: Sr. Advisor, Compliance & Quality

The Minneapolis Heart Institute Foundation® (MHIF) strives to create a world without heart and vascular disease.  As a member of the MHIF team, you will make a difference by enabling cardiovascular and vascular research and education that ultimately changes the lives of patients. Now in its 40th year, MHIF is one of the leading non-profit cardiovascular research and education institutions in the country. We exist to create a world without heart disease and our mission is to improve people’s lives through the highest quality cardiovascular research and education.  With over 80 high caliber employees, we conduct cutting-edge clinical research and transformative community research.  

The Sr. Advisor is responsible for the development, support and oversight of key compliance areas within Minneapolis Heart Institute Foundation. With the VP, Compliance, Quality & Regulatory, the Sr. Advisor will help build a comprehensive, enterprise compliance program at MHIF and will help engage others and promote adherence to applicable laws, regulations and ethical conduct of business at MHIF and identify and address potential areas of risk. This individual will take on significant ownership and responsibility for specific compliance areas as determined by experience, organizational need and interest will serve as a key organization-wide resource.

 

Essential Functions:

  • Identify compliance strengths, risk vulnerability and issues, and lead projects and policy design, coordinate compliance- and regulatory-related communications, and prioritize policy and program development to mitigate risks.
  • Working with the executive team and senior leadership, will ensure that compliance- and risk-related concerns are addressed in a timely and appropriate manner
  • Monitor and analyze the impact of new laws, regulations, enforcement actions, new research initiatives and opportunities that influence MHIF operations and revise strategy as needed.
  • Develop and maintain organization-level policies and Standard Operating Procedures (SOPs) intended to ensure compliance with applicable regulatory requirements and minimize risk.
  • Work collaboratively with all MHIF employees as part of a positive work culture.

 

Key Responsibilities:

Quality Program Development

Establish a quality system to assess and demonstrate compliance performance, including specifically both investigator-initiated and industry-sponsored research, as well as other non-research areas of operations as needed (e.g. imaging core lab).  Routinely report out to senior leadership and the Board on KPIs and other quality measures.

Data Privacy and Security

Establish and implement MHIF-wide controls for ensuring data privacy and security across all areas.  Serve as the primary regulatory contact/Officer for purposes of HIPAA and GDPR compliance.  In conjunction with MHIF’s IT leadership, routinely assess and monitor cybersecurity risks and controls.

Additional Areas of responsibility and/or support may include, but are not limited to:

  • Board Compliance.  Ensures Board members receive appropriate initial and ongoing Board compliance education.   Oversee implementation and execution of Board-related policies, including COI management.  
  • Conflict of Interest Management.  Develops and oversees policies and processes related to review and management of perceived and actual conflicts of interest across the organization.  Manages a Conflict of Interest Committee and ensures auditable documentation is maintained.
  • Policies & SOPs.  Manages policy and SOP oversight for the organization as a whole.  Works with department leaders to ensure policies and SOPs are accessibly stored, internally consistent, reviewed regularly, and modified to conform with changes in underlying regulations or other requirements.
  • Scanning & Interpretation of New Regulations.  Scan, evaluate and translate for implementation changes in applicable laws, regulations, guidance, Federal agency expectations and national practice standards.

 

Relationships:

This position reports to the VP, Compliance, Quality & Regulatory functioning as a consultant, advisor, supporter and change enabler to organizational leaders across multiple areas. This professional interacts regularly with MHIF leadership and staff, the MHIF Board of Directors, physician leaders, leaders from external organizations MHIF collaborates with, and federal and state regulatory agency representatives, as needed.  Currently this role has no direct reports but trains, provides direction and feedback to other staff supporting the work; may include a direct report in the future.

 

Qualifications:

Required

  • Bachelor’s degree in related field or equivalent experience.
  • A minimum of 6-8 years of progressive, diverse and recent compliance experience in healthcare or another highly-regulated industry.
  • Intermediate-to expert-level experience in one or both of the following as described above: Quality Program Development, Data Privacy & Security.
  • Demonstrable leadership in compliance planning, risk assessment and policy development.
  • Expert-level knowledge and experience interpreting and applying federal and state regulations and guidance to operations.
  • Ability to evaluate project needs, determine approaches, evaluate impact of alternatives and make viable strategic recommendations.
  • Demonstrated ability to simultaneously manage multiple projects and stakeholders.
  • Highly skilled in verbal and written communication; ability to present complex ideas to a variety of audiences.  Effective in interpersonal relationships, this person has influence and change management skills
  • Demonstrate the highest level of integrity and ethics.

Preferred

  • Juris Doctor.
  • Professional certifications in health care compliance (CHRC, CHC, CHPC, CCEP, etc.).
  • Healthcare compliance and/or clinical research experience.  

 

Location and Physical Demands:

This position ideally has, at a minimum, some in-office time (hybrid) also with attendance at key meetings.

Ability to sit and work at a computer for long periods of time and travel locally to meet with key stakeholders and attend critical events and functions.

 

Additional Comments:

This job description represents the major functions of the position but is not intended to be all-inclusive. 

 

Apply to join our talented 80+ person team:

Please visit our website or apply directly using the following link:

Apply Here

Minneapolis Heart Institute Foundation is an EEO/Affirmative Action employer.

Date posted: October 28, 2022