Clinical Research Specialist (Us Remote Or Northridge)

In this exciting role as a Clinical Research Specialist in the Diabetes business, you will be responsible for leading and supporting multiple activities for the optimal conduct of Clinical Research, as well as driving clinical initiatives, working with site personnel, cross-functional communication and collaboration on key clinical issues and administrative responsibilities to ensure compliance with applicable regulatory standards, IRB policies, and Medtronic internal requirements.

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We’re committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

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 position can be remote in the US or hybrid in Northridge, CA. There may be a need for up to 20% domestic travel to support the business.

A Day in the Life

• Primary responsible for leading or supporting the clinical trial lead on the designs, plans, and implementation clinical studies consistent with global clinical evidence strategies.
• 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.
• 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.
• Support or lead efforts for vendor selection, negotiation and execution of contracts and payments
• May performs site visits to train and coordinate clinical studies.
• Reports on progress and results of clinical investigations
• Performs clinical operational support to a study in collaboration with the Clinical Study Manager during all phases of the clinical study.
• Specific activities performed may include site management responsibilities, assisting in development of study and regulatory documents and reports, supporting data review and data quality management, conducting vendor reviews, creating training materials, conducting study trainings, driving & tracking study enrollment, ensuring global data protection & privacy policies are met, coordinating device accountability and providing direct communication and support to site personnel.
• Ad hoc projects as assigned in the optimization of procedures and processes. Identify barriers of inefficiencies to flush out and streamline best practices.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelor's degree with a minimum of 2 years of Clinical Research experience

OR

Nice to Have

• Degree in engineering, life sciences, or related medical/scientific field.
• Knowledge of Diabetes
• Clinical Research experience at Medtronic or within the medical device industry or pharmaceutical industry.
• CCRA certification (Certified Clinical Research Association), ACRP, CCRP, SOCRA, or equivalent preferred.
• Experience in sponsor-initiated clinical trial experience managing clinical site personnel
• Experience with Good Clinical Practice (GCP), ISO14155 and/or regulatory compliance guidelines for clinical trials/data collection.
• Ability to appropriately apply different standards related to medical devices/ Clinical Research (SOPs, GCP, ISO, ICH, FDA, MedDev, etc.), as needed.
Ability to incorporate and adhere to applied standard practices and regulatory standards.

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.

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.

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 provided base salary range is used nationally in the United States (except in Puerto Rico and certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.