Humera - Administrative and Professional Staffing

Clinical Coordinator

7 days left

Location
Plymouth, MN, United States
Salary
Contact For Rate
Posted
Jul 11, 2018
Closes
Jul 25, 2018
Job Type
Employee
Employment Status
Full Time
Humera is hiring for a Clinical Coordinator position at a medical technologies company in Plymouth,MN. Our client is committed to innovating for life by pushing the boundaries of medical technology and changing the way the world treats chronic disease.
This is a long-term, contract assignment.

Duties

Provide support to Clinical Project Teams
  • Assist with preparation for monitoring visits, such as internal regulatory file reviews and preparation, as appropriate for the assigned study
  • Maintain records of investigational devices for all assigned regulated studies
  • Facilitate the order and release of clinical IDE device inventory
  • Process invoices as needed and review payment report if applicable
  • Run IRB renewal status report and notify sites of pending IRB renewals
  • Create site regulatory/subject binder(s) and ship to sites
  • Assist with collection of site activation documents
  • Organize and track shipment of study related documents
  • Support and track shipment of project related equipment/data between centers, sponsor and core labs
  • Assist with core labs such as tracking receipt of test results and invoices
  • Attend project related meetings; write meeting minutes as applicable
  • Assist with Investigator/Committee, etc. meetings such as travel arrangements, hotel, conference rooms, etc
  • Collect, file and de-identify adverse event source documents
  • Receive and file study related documents in the appropriate location
File Management
  • Set-up and maintain Clinical Trial Master File
  • Set-up and maintain site study files
  • Maintain source document files

Requirements

  • High school diploma
  • Proficient in operating a personal computer and in using various PC-based software packages including Microsoft Word, Excel, or similar word processing/spreadsheet software
  • Must have strong organizational skills and attentiveness to detail
  • Must also have verbal and written communication, interpersonal, organizational and basic math skills
  • The ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech, demonstrated comprehension skills, and demonstrated competence in English spelling, grammar and punctuation
  • Must be able to use discretion and handle sensitive/confidential information
  • The ability to work independently when necessary
  • Must be able to maintain regular and predictable attendance
Your preferred qualifications and education:
  • A general familiarity with cardiac, vascular, and/or neuromodulation technologies, and clinical research processes
  • Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment
  • Previous Customer Service experience including interacting with customers, answering customer questions and providing information

Schedule

    Monday - Friday 8:00 am to 4:30 pm

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