Clinical Trials Coordinator

1 week ago

Sunrise Manor, Nevada, United States Terumo Aortic Full time
Clinical Trials Assistant Job Description

At Terumo Aortic, we are committed to transforming the treatment of aortic disease worldwide. Our comprehensive portfolio of surgical, endovascular, and hybrid technologies enables physicians to find the right fit for each patient anatomy.

We have a global presence with over 1,250 associates worldwide, with manufacturing facilities in Glasgow, Scotland, and Sunrise, Florida. Our company is focused on the continued development of new and innovative products, driving business growth globally.

Position Overview

The Clinical Trials Assistant will provide administrative, organizational, technical, and project management support to the Study Manager for new and ongoing medical device trials.

Key Responsibilities:

  • Maintain study information on various databases, tracking this information and filing as necessary.
  • Assist the Clinical Operations Manager in creating, processing, distributing, and managing study-related documents.
  • Coordinate and schedule team meetings and teleconferences with internal and external participants, and generate meeting minutes.
  • Manage team calendars, travel arrangements, and expense reports.
  • Set up and maintain project files, both computer and hard copies.
  • Serve as a liaison between the Clinical Operations Manager, study centers, regional monitors, and Clinical Research Organization.
  • Communicate with the Clinical Operations Manager as required for study implementation and problem resolution.
  • Track site monitoring frequency and monitoring report submission.
  • Track Pre-Study, Initiation, Interim, and Close-Out Monitoring Visits.
  • Coordinate technical support for implants and maintain calendars and implant schedules.
  • Review data and outstanding/resolved queries to determine site payments and inform accounting when payments are to be issued.
  • Review Adverse and Serious Adverse Events.
  • Process and track Clinical Trial Agreements.
  • Identify and select new study centers.
  • Set up new study centers, including sending out study start-up material, providing assistance, coordinating IRB submission, etc.
  • Prepare correspondence to sites, including mailings, memos/notes to file, etc.
  • Coordinate Investigator Meetings.
  • Manage clinical payable, including collecting vendor information for vendor setup, processing invoices with Accounts Payable, and processing invoicing information in SAP and VIM.
  • Support process improvements to the vendor and invoicing process, researching complex vendor statements, phone calls, and discrepancies.
  • Support Quality Management System Documentation control process.
  • Perform various clerical duties, including filing, mailing, faxing, creating site files, etc.

Internal Networking/Key Relationships:

  • This position requires cooperation with different company departments, such as Regulatory, Finance, IT, HR, and Quality, as well as other Clinical team members.

Minimum Skills and Capabilities:

  • Excellent written and verbal communication skills.
  • Ability to interact with all levels within internal and external organizations.

Minimum Knowledge and Experience Required for Position:

  • B.S. in healthcare/life sciences (strongly preferred).
  • Five years' experience in commercial, scientific, laboratory, or administration environment.
  • Extremely detail-oriented and organized, with excellent communication and administrative skills.
  • Able to manage multiple tasks simultaneously.
  • Excellent computer skills, including expertise in Microsoft Office Programs; familiarity with IBM/Lotus Notes beneficial.
  • Good understanding of the clinical trial process and regulatory requirements (preferred).

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