At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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:

• Bachelors with 2 years of experience working on Consent/Informed Consent (IC)/contracts within Clinical Research

Nice to Have:

• Bachelors 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 crossfunctional 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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.