Clinical Research Specialist - NV - Fridley, MN; Irvine, CA or Lafayette, CO (Onsite).
About The Position
The Clinical Research Specialist supports execution of clinical studies within Medtronic’s Neurovascular Operating Unit. Working closely with Clinical Study Managers and cross-functional partners, the role supports clinical site management, study documentation, data quality, and operational activities to ensure studies comply with applicable regulations, study protocols, and internal requirements. The Neurovascular Operating Unit develops device-based therapies and technologies for diagnosing, treating, and managing neurovascular conditions. Its teams work across clinical, regulatory, medical, and product development functions to generate clinical evidence supporting product development, regulatory submissions, and patient access to therapy. The preferred locations are Fridley, Minnesota; Irvine, California; or Lafayette, Colorado. Local Return to Office requirements will apply when relevant.
Requirements
- High school diploma or equivalent and 6 or more years of relevant experience, or an associate degree and 4 or more years, or a bachelor's degree and 2 or more years, or an 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.
Nice To Haves
- Degree in Engineering, Life Sciences, or a medical or 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 ICH, FDA, MDR, and ISO requirements.
- For baccalaureate degrees earned outside the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- 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.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- For regular employees working 20 or more hours per week: health, dental, and vision insurance; Health Savings Account; Healthcare Flexible Spending Account; life insurance; long-term disability leave; dependent daycare spending account; tuition assistance or reimbursement; and Simple Steps global well-being program.
- For all regular employees: incentive plans; 401(k) plan with employer contribution and match; short-term disability; paid time off; paid holidays; Employee Stock Purchase Plan; Employee Assistance Program; Non-qualified Retirement Plan Supplement subject to IRS earning minimums; and Capital Accumulation Plan for Vice Presidents and above or subject to IRS earning minimums.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
