Clinical Research Specialist, ICT

In this exciting role as a Clinical Research Specialist (CRS), you will be responsible for conducting clinical studies in compliance with applicable clinical and regulatory standards and in alignment with Medtronic business needs. You will monitor progress and results of clinical investigations in preparation for device application and/or publications. You will be responsible for managing and meeting the objectives of a clinical study.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We are working onsite a minimum of 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.

Responsibilities may include the following and other duties may be assigned:

• Collaborate and partner with a cross-functional team which includes study management, safety, stats, monitoring, our field team, and others
• Work closely with hospitals participating in our clinical research studies ensuring they have the support from start-up through closure
• Drive the collection of study materials throughout the lifecycle of a clinical study ensuring the regulatory documents are maintained, data is being entered into the EDC, and ensuring prompt responses from site personnel
• Oversee and manage operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations
• Conduct registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential
• Oversee and interpret results of clinical investigations in preparation for new device or consumer application
• Serve as liaison between program management and planning, study team, and leadership
• May be responsible for clinical supply operations, site and vendor selection
• Build and maintain optimal relationships and effective collaborations with various internal and external parties
• Drive local evidence dissemination & awareness
• Collaborate closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates
• Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives
• Develop, maintain, and continuously improve the project management process, guidelines, tools / templates, best practices, and overall implementation

• Degree in engineering, life sciences, or related medical/scientific field
• CCRA certification (Certified Clinical Research Association), SOCRA
• Clinical research/clinical trials experience at Medtronic or within a medical device industry
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
• Experience with Oracle Clinical, Veeva Vault, Medidata
• Experience managing multiple clinical research sites with proven results in study execution
• Experience in clinical operations
• Experience developing clinical strategies and study design
• Experience working on a global study team
• Experience in Research and Development (R&D)
• Project/program management skills/experience
• Ability to appropriately apply different standards related to medical devices/clinical research (SOPs, GCP, ISO, ICH, FDA, MEDDEV, MDR, etc.) as needed
• Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications

Must Have (Minimum Requirements):

• Bachelor's degree and a minimum of 2 years of clinical research experience
• Or advanced degree with 0 years of experience

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.

3.83.8 out of 5 stars Mounds View, MN $83,200 - $124,800 a year - Full-time, Pulled from the full job description

• Tuition reimbursement
• Employee stock purchase plan
• 401(k)
• Health insurance
• 401(k) matching
• Paid time off
• Vision insurance, 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.

Salary ranges for U.S (excl. PR) locations (USD):$83,200.00 - $124,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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 , and Simple 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 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) , and Capital 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

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.