Clinical Research Associate

Consultant, Clinical Research Associate, Medical Devices

Summary

Our client, a leading global medical device company, has engaged GForce Life Sciences to provide a Clinical Research Associate to participate in the planning and execution of clinical studies at the assigned study sites. Supports timely site activation, compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards during study activation, execution and close out phase in close cooperation with the assigned Site Management team. Uses existing procedures to solve routine or standard problems. Supports collection of essential regulatory documents, obtaining missing data and data corrections, and review of protocol deviations in cooperation with Data Review.

Responsibilities

• Supports regulatory and clinical protocol compliance for all clinical projects at the assigned sites.
• In partnership with the assigned field staff and in-house personnel, coordinates the start-up, maintenance and close out of the assigned clinical study sites.
• May review informed consent documents to ensure all required elements are included.
• Reviews and analyzes study data, regulatory documents for accuracy and completeness, supports data queries resolution.
• Supports the follow-up and resolution of findings from monitoring visits and audits on the assigned study sites.
• Serves as a liaison to clinical study management, site management personnel and site personnel by responding to protocol-related issues and escalating as appropriate.
• Acts as a primary contact for the assigned study sites.
• Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
• Applies general clinical research processes and regulatory knowledge to process improvement activities.
• Supports training of external clinical professionals to ensure compliance with established protocols.
• Performs review of site compliance under supervision and escalates issues to site operations management and/or study management.
• Updates and maintains internal clinical trial information and document management systems including trial master file management.
• Collect and maintain regional and study site-specific communication to facilitate activation and execution of clinical studies at the assigned study sites.

Requirements

• Bachelor’s degree, preferably with an academic focus in natural science, pre-medicine, nursing, or bioengineering
• 2 years of experience in clinical research
• Medical device experience required

Terms & Start

• 6+ month contract, possibility of extension
• Hybrid in Hennepin County, MN (4 days/week onsite)
• Start June 1st
• Benefits included (Medical, Dental, Vision)