Informed Consent Specialist

We anticipate the application window for this opening will close on - 26 Apr 2026 At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Informed Consent Specialist (ICS) serves as the primary point of contact for Medtronic study teams and external research centers for informed consent (IC) template development and IC related activities during Institutional Review Board/Ethics Committee (IRB/EC) approvals and renewals. The ICS will develop strong working relationships with research centers and a familiarity with study participant matter in order to accelerate research center initiation cycle times and foster strong partnerships. The ICS will partner with other internal Medtronic functions such as field clinical personnel, contract analysts, study team members, monitors and legal departments to accomplish these goals. Works under general supervision. Work is reviewed for soundness of technical judgment, Medtronic standard operating procedure (SOP)/regulatory/legal compliance and overall adequacy. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. Responsibilities may include the following and other duties may be assigned. Informed Consent Management

• Act as primary contact for assigned clinical studies and associated clinical sites for all activities related to ICs ( as agreed upon by study team );
• Coordinate activities of internal and external stakeholders to assure the timely, accurate and regulatorily compliant completion of the IC approval process;
• Lead IC development with clinical sites, field personnel and study teams;
• Customize ICs based on clinical site and IRB/EC/REB specifics learned from collaboration during prior studies;
• Provide appropriately organized documents to internal MDT stakeholders to ensure accurate and timely IC review;
• Collaborate with Contracts function to ensure alignment between clinical trial agreements (CTA) and their associated IC;
• Act as single point of contact (“Lead ICS”) for all IC-related questions from study teams of assigned studies, including attendance at study team leadership meetings and providing study status updates;
• Attend investigator/coordinator meetings as needed-train on research center initiation practices

Document Management:

• Create and maintain accurate IC files; ensure receipt and storage of proper documentation; ensure proper legal, study team, and IRB/EC approvals and storage thereof;
• Document key IRB/EC and center specific learnings;
• Identify and actively resolve issues related to IC documents;
• Perform periodic audits of IC files for completeness and actively drive completion of action items;
• Accurately update and maintain internal tracking systems (online clinical trial management system)

Relationship Management:

• Partner with other internal Medtronic functions (e.g. contract analysts, study team members, field personnel, legal, monitoring, etc.) to meet or exceed customer expectations;
• Develop a thorough understanding of assigned research centers’ and studies’ processes and practices;
• Demonstrate ability to foster strong partnerships with assigned research centers’ coordinators and other research center personnel, as needed; and,
• Actively train and mentor ICSs within team,
• Initiate and support development of process improvement initiatives; and,
• Utilize applicable SOPs, policies and practices for guidance. Communicate with senior leadership on SOP interpretation and provides SOP guidance to other MDT employees.

Minimum Requirements:

• Bachelor's with 2+ years of experience working on Consent/Informed Consent (IC)/contracts within Clinical Research

Nice to Have:

• Bachelor’s degree in Clinical Research, Life Sciences, Biology, Chemistry, or related field
• Exposure to IRB/EC/REB submission and approval processes
• Familiarity with informed consent documents and basic clinical research regulations (e.g., GCP)
• Experience working with cross‑functional partners such as study teams, contracts, or legal in a clinical research setting
• Prior experience supporting multiple studies or sites simultaneously
• Medtronic experience or experience in a regulated medical device or pharmaceutical environment

For Baccalaureate degrees earned outside of the United States, a de Apply tot his job Apply To this Job