Clinical Research Specialist

Job Title - Clinical Research Spec

Job Location Type - In person

Location – Mounds View, Minnesota 55112

Job type – 24 months

Shift Schedule – 1st shift

Job Description -

We are seeking a Clinical Research Specialist to support the design, execution, and oversight of clinical studies for medical devices. This role partners with cross-functional teams, manages site activities, and ensures clinical operations align with Good Clinical Practice (GCP), study protocols, and regulatory requirements.

Key Responsibilities -

• Support planning and operational execution of clinical studies from design through implementation.
• Perform site management activities, ensuring compliance with study protocols and GCP.
• Maintain and update CTMS, EDC, and TMF systems (e.g., Veeva Vault, Rave, Oracle).
• Prepare and review study documents including protocols, CRFs, and patient-related materials.
• Monitor study progress, resolve operational issues, and support clinical data integrity.
• Coordinate with internal stakeholders to track milestones and ensure study deliverables are met.
• Assist with vendor and site selection, budget preparation, and clinical supply oversight.
• Contribute to reporting, documentation accuracy, and continuous process improvements.
  
  

Required Qualifications -

• Bachelor’s degree in engineering, life sciences, medical, or related scientific field.
• Minimum 2 years of experience in clinical research or clinical operations.
• Hands-on experience with CTMS/EDC/TMF systems and patient/site management tools.
• Knowledge of GCP, SOPs, and applicable country regulations.
• Proficient in Microsoft Office applications.
• Strong communication, organization, and problem-solving skills.