Description
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**
**Careers That Change Lives**
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.
**Peripheral Vascular Health Operating Unit**
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.
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 ()
Location: Remote within the U. S; preferred location(s): Santa Rosa, CA / Northern California - Bay Area / Plymouth, MN
Ability to travel up
**A Day in the Life**
Responsibilities may include the following and other duties may be assigned.
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.
People working within region/country may also have the responsibilities that include:
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
.
**Must Have (Minimum Requirements):**
**To be considered for this role, the minimum requirements must be evident on your resume.**
Bachelor's degree and a minimum of 2 years of clinical research experience or advanced degree with 0 years of experience
**Nice to Have (Preferred Qualifications):**
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
**About Medtronic**
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 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
Compensation Information:
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Up To: 0.0
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