Informed Consent Specialist

Medtronic • Minneapolis, MN

23h • Remote

About The Position

At Medtronic, the Informed Consent Specialist (ICS) plays a crucial role in championing healthcare access and equity by serving as the primary point of contact for Medtronic study teams and external research centers. This role is responsible for informed consent (IC) template development and all IC-related activities during Institutional Review Board/Ethics Committee (IRB/EC) approvals and renewals. The ICS is expected to build strong working relationships with research centers and develop familiarity with study participant matters to expedite research center initiation cycle times and foster robust partnerships. Collaboration with various internal Medtronic functions, including field clinical personnel, contract analysts, study team members, monitors, and legal departments, is essential to achieve these objectives. The position operates under general supervision, with work reviewed for technical judgment, adherence to Medtronic standard operating procedures (SOPs), and regulatory/legal compliance. Medtronic is a global healthcare technology leader dedicated to solving challenging health problems and improving human welfare. The company's mission is to alleviate pain, restore health, and extend life, driven by a global team of 95,000+ passionate individuals who are engineers at heart, constantly innovating and building extraordinary solutions. This specific position is remote, aimed at enhancing competitive edge and expanding cross-functional collaboration.

Requirements

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

Nice To Haves

• 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

Responsibilities

• 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
• 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)
• 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
• Actively train and mentor ICSs within team
• Initiate and support development of process improvement initiatives
• Utilize applicable SOPs, policies and practices for guidance
• Communicate with senior leadership on SOP interpretation and provides SOP guidance to other MDT employees

Benefits

• Competitive Salary and flexible Benefits Package
• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans (Medtronic Incentive Plan (MIP))
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
• Paid sick time (for temporary employees, as required under applicable state law)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees