Senior In-house CRA – LATAM

Posted 2hrs ago

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Job Description

Senior In-house CRA providing clinical research support for expanding operations in Mexico and LATAM region. Focused on building foundation through study site support and adherence to regulatory requirements.

Responsibilities:

  • Provides overall support to study sites and clinical project teams engaged in clinical research studies
  • Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements
  • Acts as a point of contact for study sites
  • Schedules internal and external meetings as required
  • Prepares Investigator Site Files including distribution to study sites
  • Performs ongoing essential document collection and review, maintenance, and close-out activities
  • Assists with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials
  • Ensures timely and complete data entry by site in EDC or any other system that requires data entry
  • May serve as an Independent Essential Document Reviewer post-SIV by supporting on-site visit activities

Requirements:

  • Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
  • 4 years of clinical trial or related experience
  • High in proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
  • Fluency in English communication, verbally and in writing
  • In-depth knowledge of the drug development process
  • Experienced with utilizing CTMS, TMF, and EDC systems
  • Ability to travel as needed

Benefits:

  • Health insurance
  • Customer service demeanor; demonstrate flexibility and teamwork
  • Professional development opportunities