Clinical Evidence Specialist

Histo Sonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.

Location: Plymouth, MN

Workplace: Remote, with periodic visits to the Plymouth, MN office for meetings and events.

Position Summary:

The Clinical Evidence Specialist is responsible for managing Histo Sonics' Investigator-Sponsored Research (ISR) program and contributing to clinical evidence management and dissemination. The ideal candidate will be highly organized and detail-oriented. The Clinical Evidence Specialist will play an important role in driving histotripsy evidence generation and dissemination.

Key Responsibilities:

• Lead Investigator-Sponsored Research (ISR) Program
  • Manage the full lifecycle of ISR studies, from proposal receipt and scientific review to contracting, funding, and study execution.
  • Serve as the primary liaison between the company and investigators, institutions, and vendors.
  • Coordinate internal ISR Committee review to evaluate proposals and establish research priorities.
  • Track ISR study progress, key milestones, and deliverables.
  • Manage ISR database and dashboard for metrics, reporting, and audits.
  • Develop and implement operational strategies for efficient review, approval, and execution of ISR proposals and studies.
  • Support data-sharing, publication, and communication of ISR study outcomes to maximize scientific impact.
  • Ensure compliance with SOPs, company policies, and applicable regulations (e.g., FDA, OIG, ICH, GCP) for all ISR-related activities.
• Evidence Management and Dissemination
  • Review literature, news alerts, and medical conference programs for pertinent publications/presentations.
  • Disseminate relevant literature to key stakeholders.
  • Manage company's centralized bibliography.
  • May review materials to ensure appropriate evaluation and presentation of clinical data.
  • Assist with the execution of the publication and presentation strategy for company sponsored studies.

Qualifications and Skills:

• Bachelor's degree required; degree in science, medicine, or similar discipline, with 1+ years related research experience is highly preferred.
• Strong organizational and follow-up skills, as well as attention to detail.
• Excellent written and verbal communication skills, with the ability to effectively communicate at multiple levels in the company, and with physicians and research staff.
• Proficiency in research tracking systems, budget management, and Microsoft Office or equivalent tools.
• Strong analytical, critical thinking, and problem-solving skills with the ability to interpret and analyze data.
• Ability to collaborate in a team environment and work independently.
• Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills.

Histo Sonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Benefits:
We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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