Clinical Research Specialist at Medtronic in Mounds View, Minnesota

Job Description:

Careers that Change Lives

In this exciting role as a Clinical Research Specialist within the Structural Heart and Aortic Operating Unit, you will have primary focus and responsibility for study execution and clinical study site management on a key clinical program to support the development and advancement of best-in-class transcatheter mitral therapies. You will work under the direction and closely with the Clinical Manager to satisfy applicable regulatory standards and Medtronic internal requirements for clinical studies.

The Structural Heart and Aortic integrated operating unit offer minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves-aortic, pulmonic, mitral, tricuspid-and the placement of stent grafts to treat aneurysms and dissections of the body's largest artery, the aorta. This role will be within the mitral and tricuspid clinical group .

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It's no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it's the only way to drive healthcare forward and remain a global leader in medical technology and solutions.To learn more about Inclusion & Diversity at Medtronic Click Here

This role is open to remote work.

A Day in the Life
Responsibilities may include the following and other duties may be assigned.

• Reviews and approves required documents for study start, assures continued validity of such documents, takes actions for updates and/or replacements, and monitors site activation
• Performs site initiation activities, resolution and follow-up of site issues, and study closure activities.
• Provides support and training for clinical study sites to assure data integrity and protocol compliance. Prepares study materials and/or training and tracks and maintains study documentation. Prepares clinical case summaries. Sets up and maintains accurate clinical study files.
• Coordinates activities of associates (assigned clinical staff) and investigators to ensure compliance with CIP and overall clinical objectives
• Perform site file reviews
• Oversees and resolves 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.
• Participates in overall clinical management plan, protocol and case report form development.
• Performs data review, reviews data discrepancies, ensures data queries are being resolved, works closely with monitors to ensure monitoring action items are resolved, and generates reports.
• Reports on progress and results of clinical investigations
• May be responsible for clinical supply operations, site and vendor selection.
• Builds and maintains optimal relationships and effective collaborations with various internal and external parties.
• Assists clinical management with other duties as requested .

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

• B.S Degree in life sciences, or related medical/scientific field.
• Experience conducting/working on clinical studies and managing clinical trial data review
• Clinical Research experience at Medtronic or within a medical device industry, preferably incardiovasculararea
• CCRA, CCRP or CCRC certification
• Strong knowledge of clinical monitoring functions and clinical research methodologies, including study design, implementation, and reporting.
• Experience with Clinical Operations and interfacing with CRO (Contract Research Organization) teams.
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
• Excellent project management, critical thinking, and organization skills - evident on your resume from previous positions .

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

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. (ADA-United States of America)

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. Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

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).