Clinical Research Specialist - NV ; Irvine, CA or Lafayette, CO; Onsite

Onsite

Fridley, Minnesota, United States of America

Lafayette, Colorado, United States of America

Irvine, California, United States of America

Full time

R79139

We anticipate the application window for this opening will close on - 17 Oct 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

At Medtronic Neuroscience, we bring innovation, expertise, and purpose together to improve care for people living with neurological, spinal, and chronic pain conditions. Our technologies help restore function, improve quality of life, and support better outcomes for patients around the world.

The Neurovascular Operating Unit develops device-based therapies and technologies that support the diagnosis, treatment, and management of neurovascular conditions. The team partners across clinical, regulatory, medical, and product development functions to generate clinical evidence that supports product development, regulatory submissions, and patient access to therapy.

Preference for this position is Fridley, MN, Irvine, CA or Lafayette, CO. If the selected candidate is subject to local Return to Office requirements, those requirements will be followed.

The Clinical Research Specialist supports the execution of clinical studies within the Neurovascular Operating Unit. Working closely with Clinical Study Managers and cross-functional partners, this role is responsible for clinical site management, study documentation, data quality activities, and operational support to ensure studies are conducted in compliance with applicable regulations, study protocols, and internal requirements.

• Manage clinical study sites from activation through closeout, including site initiation, training, issue resolution, and ongoing support.

• Review, approve, and maintain regulatory and study-startup documentation to support site activation and continued compliance.

• Coordinate investigator and site staff activities to ensure protocol adherence, data quality, and achievement of study objectives.

• Maintain clinical study files, essential documentation, training materials, and study records.

• Review clinical data, resolve data discrepancies, track open queries, and partner with monitors to address study action items.

• Support development and execution of clinical management plans, protocols, case report forms, and study-related documentation.

• Monitor study progress and prepare reports on clinical investigation activities, milestones, and results.

• Collaborate with internal and external stakeholders, including study sites, vendors, and cross-functional teams, to support successful study execution.

• High School Diploma (or equivalent) and 6+ years OR Associate's Degree and 4+ years OR Bachelor's Degree and 2+ years OR Advanced Degree in clinical research, clinical operations, or related clinical study support experience.

• Experience supporting clinical studies and clinical site management activities.

• Experience working in compliance with Good Clinical Practice (GCP) requirements.

• Experience reviewing clinical data, resolving discrepancies, and maintaining study documentation.

• Degree in Engineering, Life Sciences, or a medical/scientific discipline.

• Certified Clinical Research Associate (CCRA) or Society of Clinical Research Associates (SOCRA) certification.

• Clinical research experience within the medical device industry.

• Experience managing multiple clinical research sites and supporting clinical operations activities.

• Knowledge of clinical research regulations and standards, including International Council for Harmonisation (ICH), Food and Drug Administration (FDA), Medical Device Regulation (MDR), and International Organization for Standardization (ISO) requirements.

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.

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…