Manager - General Compliance

Building Location:

6th Ave Building

Department:

48150 Org Integrity & Compliance

Job Description:

Responsible for the planning, development, and implementation of designated services for the system-wide integrity & compliance function. Assists the Compliance Director and the Chief Compliance Officer in overseeing the implementation and operation of the Essentia Health Organizational Integrity & Compliance Program (“Program”) and in developing Program strategy and system-wide processes. As assigned, the Manager is responsible for implementing elements of the Essentia Health Program consistent with the overall Program. Position requires an elevated level of customer service skills to establish and enhance positive relationships with patients, co-workers, and others.

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.

Licensure/Certification Qualifications:

Certification/Licensure Requirements:

• Certification in Healthcare Research Compliance (CHRC), Certified IRB Professional (CIP), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC) or similar designation required (or to be obtained within twelve (12) months of hire)

FTE:

1

Possible Remote/Hybrid Option:

Remote

Shift Rotation:

Day Rotation (United States of America)

Shift Start Time:

8:00 am

Shift End Time:

5:00 pm

Weekends:

Holidays:

No

Call Obligation:

No

Union:

Union Posting Deadline: