Regulatory Affairs Specialist II

2 weeks ago

Minneapolis, Minnesota, United States Mlnneapolis heart institute foundation Full time

The Minneapolis Heart Institute Foundation (MHIF) is on the lookout for a dedicated Quality & Regulatory Affairs Specialist II to help advance MHIF's mission of eradicating heart and vascular diseases. Our commitment is to enhance cardiovascular health through pioneering research and educational initiatives. With over four decades of experience, MHIF stands as a global leader in cardiovascular research, supported by state-of-the-art scientific centers.

This role is ideal for a professional experienced in working with Institutional Review Boards (IRBs) who is eager to take charge of and refine regulatory processes while expanding their expertise in a purpose-driven environment.

We are in search of proactive candidates who are passionate about making a positive impact and who demonstrate high integrity, initiative, adaptability, and a constructive mindset. In this position, you will act as a key resource for IRB and regulatory matters. You will facilitate communication between MHIF, industry sponsors, and the various IRBs that MHIF collaborates with, ensuring timely IRB approvals for new research initiatives and the efficient management of regulatory correspondence. Under the guidance of the Director of Quality & Regulatory Affairs, the Specialist II will support internal quality assessments of research projects and assist in managing policies and Standard Operating Procedures (SOPs) across the organization.

Key Responsibilities:

  • Serve as a knowledgeable resource for research staff and investigators regarding the interpretation and application of internal and external IRB reporting standards, as well as relevant Health Insurance Portability and Accountability Act (HIPAA) and Food and Drug Administration (FDA) regulations.
  • Support the Scientific Services team in drafting and refining investigator-initiated study protocols to align with IRB requirements and regulatory standards, including HIPAA and FDA guidelines. Collaborate with external partners on regulatory matters and IRB submissions for investigator-initiated studies.
  • Engage directly with study sponsors to gather, prepare, edit, and submit IRB applications, regulatory documents, reports, and correspondence.
  • Maintain regular communication regarding the status of regulatory responsibilities with research staff, sponsors, IRBs, and other stakeholders.
  • Update and manage a comprehensive database containing essential information on all MHIF studies.
  • Organize, store, and track regulatory applications, documents, and research information in compliance with regulatory standards and MHIF protocols.
  • Develop and enhance guidelines, tools, and processes to ensure high-quality regulatory and compliance operations.
  • May oversee and provide informal guidance, training, and education to QR Administrative Assistants and QR Specialist I.
  • Assist the Director of Quality & Regulatory Affairs in managing potential conflicts of interest related to research and non-research activities in accordance with MHIF policies.
  • Lead and support the management of MHIF policies and SOPs.
  • Collaborate with cross-functional teams to provide regulatory insights and solutions.
  • Contribute to the education and training of MHIF staff on relevant research and compliance topics and regulations.
  • Participate in monitoring and auditing selected research projects to ensure adherence to applicable internal, federal, and state regulations.
  • Support the Director of Quality & Regulatory Affairs with non-research compliance requirements and special projects as necessary.
  • Work collaboratively with all MHIF employees to foster a positive and supportive workplace culture.
Relationships:

This position reports to the Director of Quality & Regulatory Affairs and may receive work direction from the VP of Clinical Research Operations. The Specialist II will collaborate closely with MHIF research personnel and other key internal and external stakeholders.

Qualifications:

Required:
  • Bachelor's Degree
  • 3-5 years of experience with regulations, particularly FDA and HIPAA, related to research conduct.
  • 3 years of experience supporting investigator-initiated research (may overlap with the above).
  • Proven strong interpersonal and written communication skills.
  • Advanced proficiency in MS Word and intermediate skills in database applications, including MS Excel, Outlook, and SharePoint.
  • Ability to think critically, exercise sound independent judgment, adapt to changing regulatory environments, and manage competing priorities.
  • Recognize and evaluate novel problems or situations without clear precedents, and develop solutions that align with MHIF and IRB policies.
  • Ability to collaborate effectively as part of a team and contribute to a positive work culture.
Preferred:
  • General understanding of common cardiovascular medical terminology.
  • Certification in clinical research, IRB, or healthcare compliance, such as CCRA, CCRC, ACRP-CP, or CIP, or a commitment to obtain certification within one year of hire.
Physical Demands:

Ability to work at a computer for extended periods.

Additional Comments:

This job description outlines the primary functions of the position but is not intended to be exhaustive.

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

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