Clinical Research Specialist

About the role

A Day in the Life: In this exciting role as a Clinical Research Specialist within the Structural Heart team, you will have primary focus and responsibility for study start up and execution on a key clinical program to support the development and advancement of best-in-class transcatheter tricuspid therapies.

Responsibilities

• Aid in designing, planning and developing clinical evaluation research studies for products that are under clinical investigation.
• Prepare and author protocols and regulatory submissions.
• Conduct registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential.
• Avoid and interpret results of clinical investigations in preparation for new device or consumer application.
• Oversee and manage operational aspects of clinical trials in conjunction with the Study Team and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets.
• Be responsible for site and vendor selection and oversight.
• Collaborate and partner with a cross-functional team which includes site managers, monitors, statisticians, field teams, and others.
• Build and maintain optimal relationships and effective collaborations with various internal and external parties.
• Assist in local evidence dissemination strategies.

Requirements

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

Nice-to-Haves

• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
• Experience in clinical operations
• Experience developing clinical strategies and study design
• Experience in structural heart therapies
• Experience working with global teams
• Project management experience

Qualifications

• To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

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.

Benefits & Compensation

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).

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.

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.