Job Description

Summary

Our client, a Fortune 500 Medical Device Company , has engaged GForce Life Sciences to provide an entry level Clinical Project Specialist role in the Study Operations Project Management team. This role participates in the execution of clinical device studies, ensures compliance to study protocol, domestic and international Good Clinical Practices, and applicable regulatory standards. This role’s dedicated focus is on study management support activities, which may include vendor oversight.

Job Duties

• Supports Clinical Project Manager in key study execution tasks
• Responsible for maintaining study-specific SharePoint sites and study-level TMF
• Develops and owns study-specific materials such as training slides, document templates (i.e. DoA, training logs), and newsletters.
• Assists with the development of study-related materials such as: SIV slides, patient brochures, patient recruitment material, and presentations.
• Review Site Activation Checklist to ensure all required elements and documents are included.
• Assists with site selection processes.
• Coordinates activities with study-specific committees, vendor services, and core labs.
• Reviews documents (e.g., study document templates and site activation regulatory documents) for accuracy and completeness.
• Provides periodic updates on site and/or study statuses, as requested by the Clinical Project Manager
• As applicable, communicate effectively with Customers/KOLs, Physician Members, National Principal Investigators, Field Clinical, Medical Directors, and Clinical Science, Research and Development, and other internal personnel.

Mandatory Requirements

• An Associate’s Degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
• Minimum 2 years of clinical research experience.

Nice to Have

• A general familiarity with cardiac and/or vascular technologies. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
• Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).

Terms & Start

• 12-month contract
• Full time, 40hrs/week
• Onsite in Greater San Francisco, Maple Grove, MN or Plano, TX
• Benefits available (Medical, Dental, Vision, 401k)

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