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HistoSonics, Inc. · 5 hours ago

Senior Clinical Research Associate

Twin Cities Area

Full-time

Hybrid

Senior Level

5+ years exp

HistoSonics, Inc. is a medical device company that has developed a non-invasive sonic beam therapy platform for treating liver tumors. The Senior Clinical Research Associate will manage clinical studies, ensuring compliance with regulatory requirements and facilitating site management activities.

Health CareMedicalMedical Device

No H1B

Responsibilities

Works on assigned studies to ensure that human subject protection is maintained in accordance with Good Clinical Practice (GCP), SOPs, and applicable regulations

Conducts on-site and remote site qualification, initiation, interim, and close-out monitoring visits

Serve as primary point of contact for site questions relating to study enrollment and conduct; collaborate with appropriate study team members as needed

Assists with the development and execution of clinical study documents including protocols, informed consents, case report forms, and study plans

Communicates through verbal and written communication with site investigator and the project team on the overall site performance, trends, deficiencies, and concerns

Ensures quality and completeness of central and site master files

Oversees site investigational product requirements and device accountability

Assists preparing sites for audits and in resolving action items

Supports site audits as needed (on-site and remote)

Supports the planning and coordination of Investigator Meetings

Other duties as assigned

Qualification

Clinical research monitoringGCPICHBS degree in relevant areaCommunication skillsInterpersonal skillsOrganizational skillsTeam collaborationSelf-starterProject management