overview

Clinical Research Field Specialist

 

Position Summary

This position reports to the Clinical Research Manager and is responsible for clinical trial site management, case coverage and clinical trial data tracking. The Clinical Research Field Specialist works closely with study sites to conduct CorPath System clinical studies designed to deliver procedural control, offer robotic precision and provide radiation safety during vascular interventional procedures. As part of a multi-disciplinary group, this position contributes to the design, development and product launch of Corindus’ innovative robotic systems that bring improved care to patients and physicians.

Primary Responsibilities

  • Case coverage or technical support assistance for clinical research procedures within the Interventional environment.
  • Responsible for gaining and maintaining knowledge of clinical sites to best understand and assess investigators' interests and capabilities.
  • Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
  • Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
  • Performs miscellaneous job-related duties as assigned. Ensuring compliance with SOPs and local regulations, and ICH-GCP guidelines.
  • Oversee preparation of and revisions to the Clinical Investigation Plan for assigned clinical studies.
  • Interface with, and assure training of investigators, site staff, and Corindus clinical staff.
  • Assist in site initiation (e.g. oversight of start-up document preparation, distribution, receipt, and review).
  • May proctor or provide case support.
  • Assist in compilation and review of adverse event information.
  • Assist in compilation, review and conclusion of device complaints.
  • Oversee activities performed by Contract Research Organizations (e.g. CROs, core labs).
  • Ability to travel 75%.

Desired Skills and Experience

  • At least 5 years of related work experience required. Strong clinical orientation. Experience in neurovascular procedures, peripheral vascular intervention and interventional cardiology; familiarity with clinical trial management also strongly preferred.
  • Degree in engineering, life sciences, or related medical/scientific field.
  • Working knowledge of Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials.
  • Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications.
  • Experience in managing clinical trial data review.
  • Ability to incorporate and adhere to good clinical practices and regulatory standards.
  • Ability to manage multiple clinical research sites with proven results in study execution.
  • Ability to identify and implement solutions in addressing study issues.
  • Basic understanding of biostatistics and trial design.
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