Manager - General Compliance

Education Qualifications:

Education Requirements:

• Bachelor’s degree in healthcare/business administration, Legal Studies, Science/Nursing, Communications, or related field of study required

Required Qualifications:

• Minimum of five years health care, academic, or pharmaceutical compliance experience or experience in a high compliance risk-related field

Preferred Qualifications:

• Word processing skills; work experience with Microsoft Office products including Word, Excel, PowerPoint, Outlook; ability to learn and utilize compliance-related software.

Key Responsibilities:

• Developing and implementing the elements of a compliance program for designated services
• Leading, and mentoring compliance colleagues
• Developing, coordinating, and leading projects
• Leading meetings related to compliance topics
• Conducting compliance investigations and determining corrective actions

As a Compliance Manager at Essentia Health you will:

• Lead a team of Research Compliance Specialists
• Assist in the implementation and operation of the Essentia Health Organizational Integrity & Compliance Program
• Assist the Chief Compliance Officer, management team, and senior compliance specialists in developing aspects of Program strategy and system-wide policies, procedures, plans and processes
• Effectively and accurately analyze laws and regulations
• Effectively communicate regulatory requirements to business leaders, physicians, researchers and other key stakeholders

As the Compliance Manager supporting Research, you will:

• Interpret and apply federal and state laws and regulations and institutional policies that protect human subjects and research processes to ensure institutional compliance
• Provide regulatory, ethical, and process advice to individual researchers in their preparation of applications for research proposals involving human subjects, including consent documents
• Provide information to Institutional Review Board (IRB) members on ethical issues and regulatory topics pertinent to IRB reviews
• Oversee the quality assurance monitoring of the HRPP, including investigation of matters of noncompliance and ensure implementation of corrective action
• Represent Essentia Health as a liaison with regulatory agencies, accrediting bodies (as applicable), and funding agencies
• Ensure compliance with HIPAA as it relates to research
• Monitor the training of researchers and IRB members regarding the ethical conduct of research involving human subjects
• Advise researchers on the preparation and completion of IRB forms and submission requirements
• Collaborate with research operations leadership to ensure regulatory compliance

This might be a good position for you if you:

• Have experience in a healthcare research setting
• Like a lot of variety - no two days are alike
• Want to make a difference in the life of patients
• Would like to play a key role in Essentia's mission of zero preventable harm
• Have an interest in learning more about healthcare and research regulations and policy
• Are interested in growing your career in research compliance

You might be a good fit for this position if you:

• Are detail- oriented
• Are comfortable working on multiple projects with various deadlines
• Have experience in customer service, especially in resolving customer issues
• Can remain calm and professional under stress
• Have a high level of integrity and respect for others
• Currently hold, or be willing to seek, one of the following certifications: Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC)

This position is remote with a preference for candidates local to the Essentia Health service area.