Neurovascular Clinical Trials Specialist

Regulatory Jobs; Fridley (MN); Presencial; USD 83.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental & vision insurance

HSA

Paid time off

401(k) plan with employer match

Employee assistance program

Descripción de la vacante

Medtronic Neuroscience is seeking a Clinical Research Specialist to manage study sites, ensure regulatory compliance, and support data quality across neurovascular clinical investigations.

Key responsibilities include site activation, documentation review, and collaboration with internal and external stakeholders to drive successful study execution in offices across Fridley, MN, Irvine, CA, and Lafayette, CO.

Formación

• 6+ years of experience with clinical studies or site management.
• Experience in ensuring compliance with GCP and regulatory requirements.
• Experience reviewing data, resolving discrepancies, and maintaining study documentation.

Responsabilidades

• Manage clinical study sites from activation to closeout, including initiation and training.
• Review and maintain regulatory and study-startup docs for activation and compliance.
• Coordinate investigator and site staff activities to ensure protocol adherence and data quality.
• Maintain study files, essential docs, training materials, and study records.
• Review data, resolve discrepancies, track open queries, and work with monitors on actions.
• Support development of management plans, CRFs, and study docs.
• Monitor progress and prepare reports on investigations and milestones.
• Collaborate with sites, vendors, and cross-functional teams for study execution.

Conocimientos

Clinical research

Regulatory compliance

Documentation management

Data review & query resolution

Educación

Bachelor's degree in clinical research or related field

Advanced degree in clinical research/operations

Herramientas

GCP knowledge

Descripción del empleo

Medtronic Neuroscience is seeking a Clinical Research Specialist to manage study sites, ensure regulatory compliance, and support data quality across neurovascular clinical investigations.

Key responsibilities include site activation, documentation review, and collaboration with internal and external stakeholders to drive successful study execution in offices across Fridley, MN, Irvine, CA, and Lafayette, CO.