Informed Consent Specialist

Medtronic•Minneapolis, MN

1d•Remote

About The Position

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.

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
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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

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
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 (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)