Clinical Research Specialist - NV - Fridley, MN; Irvine, CA or Lafayette, CO (Onsite).

COV Covidien LP (Medtronic) is hiring a Clinical Research Specialist to support clinical studies in its Neurovascular Operating Unit. The role manages clinical sites and study documentation, supports data quality and compliance, and collaborates with internal and external partners to ensure successful study execution.

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

Preferred

• 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
• life sciences
• medical-scientific degree
• CCRA certification
• SOCRA certification
• Clinical research experience
• Medical device industry experience
• Clinical research site management
• Clinical operations support
• ICH regulations
• FDA regulations
• Medical Device Regulation (MDR)
• ISO requirements

Benefits

• Eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
• For regular employees who work 20+ hours per week: Health, Dental and vision insurance
• For regular employees who work 20+ hours per week: Health Savings Account
• For regular employees who work 20+ hours per week: Healthcare Flexible Spending Account
• For regular employees who work 20+ hours per week: Life insurance
• For regular employees who work 20+ hours per week: Long-term disability leave
• For regular employees who work 20+ hours per week: Dependent daycare spending account
• For regular employees who work 20+ hours per week: Tuition assistance/reimbursement
• For regular employees who work 20+ hours per week: Simple Steps (global well-being program)
• For all regular employees: Incentive plans
• For all regular employees: 401(k) plan plus employer contribution and match
• For all regular employees: Short-term disability
• For all regular employees: Paid time off
• For all regular employees: Paid holidays
• For all regular employees: Employee Stock Purchase Plan
• For all regular employees: Employee Assistance Program
• For all regular employees: Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• For all regular employees: Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
• Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan.

Company

• Global healthcare technology company
• Minneapolis, Minnesota, USA
• https://www.medtronic.com/
• Founded in 1949
• 10001+ employees

Qualifications

• 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
• Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment
• 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
• 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.

Required skills

• CCRA Certification, Clinical Data Review, Clinical Practice (GCP), Clinical Research, Clinical Research Regulations and Standards, Clinical Site Management, FDA Regulations, ICH, ISO Standards, Medical Device Clinical Research, Medical Device Regulation (MDR), SOCRA Certification, Study Documentation

Experience

• 2+ years