Clinical Research Specialist

Medtronic • Plymouth, MN

1d • Onsite

About The Position

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 Peripheral Vascular Health therapies are a critical part of the Medtronic vascular portfolio, treating patients with a broad range of conditions, including Peripheral and Carotid Disease, End Stage Renal Disease, Peripheral Embolization, and Superficial and Deep Venous Disease. We lead the way in the Superficial Venous and Drug Coated Balloon markets, caring for hundreds of millions of patients globally with lifesaving and life-enhancing therapies. 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’re working a minimum of 4 days a week onsite 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 position will be based in Plymouth, MN. 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.

Requirements

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

Nice To Haves

• 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 managing multiple clinical research sites with proven results in study execution
• Experience in clinical operations
• Experience developing clinical strategies and study design
• Experience in Peripheral or Endovenous therapies/product
• 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
• 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

• Assist in designing, planning, and developing clinical evaluation research studies for products that are under Clinical Investigation.
• Prepares and authors protocols and patient record forms.
• Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Oversees and interpret results of clinical investigations in preparation for new device or consumer application.
• Oversees and manages 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, and may prepare clinical trial budgets.
• Serves as liaison between program management and planning, study team, and leadership
• Collaborates and partners with a cross-functional team which includes site managers, monitoring, safety, stats, and others
• Assist in reviewing status of projects and budgets; manages schedules and prepares status reports.
• May be responsible for clinical supply operations, site and vendor selection.
• Represents Medtronic from a clinical research respective within the country / region and also collects feedback from local customers and authorities.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Drives local evidence dissemination & awareness.
• Collaborates closely with medical affairs, regulatory, marketing, and other functions to gather feedback on key design elements of the trial and communicate status updates
• Assesses project issues and develops 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

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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).
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level