Clinical Operations Specialist for Clinical Trials

hace 5 horas


Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

We are seeking a highly organized and detail-oriented Clinical Operations Specialist to join our team at Worldwide Clinical Trials.

About the Role:

The Clinical Operations Specialist will be responsible for ensuring all daily aspects of operational work related to rater selection, certification/qualification, training content, scale acquisition, surveillance maintenance, and workbook/source document management are carried out in a timely fashion and in compliance with SOPs and ICH/GCP/regulatory guidelines.

Key Responsibilities:

  • Track the collection, entry, and distribution of rater experience qualification data
  • Review and develop study-specific rater training web portal specifications for portal readiness
  • Assist in coordinating logistical matters and preparing materials for Investigators' Meetings
  • Edit/format materials such as rater training, including Excel spreadsheets, PowerPoint training slides, and Microsoft Word documents
  • Conduct scale management activities, such as obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals
  • Track incoming source documentation to ensure timeliness of source reviews and provide data to the Sponsor and study team
  • Communicate with research sites to ensure rater training and data surveillance plan guidelines are followed
  • Provide CAT data for the CAT Final Study Report completion and ensure proper formatting of the document

Requirements:

  • Highly organized, detail-oriented, and service-oriented individual
  • Meets timelines consistently and able to effectively work under pressure
  • Continuously open to constructive feedback
  • Skilled in written and verbal communication to clearly present information
  • High level of interpersonal skills in a fast-paced, deadline-oriented environment
  • Able to manage multiple tasks and administrative details in a fast-paced environment
  • High level of self-motivation and ability to work in teams

Preferred Qualifications:

  • Minimum of an Associate's degree
  • At least 1+ years of clinical trial experience
  • Demonstrable knowledge of operational aspects of Phase I-IV clinical trials
  • Ample knowledge of SOPs and ICH/GCP/regulatory guidelines
  • Competency working with data and numbers
  • Fluency in English (required for day-to-day business)

Estimated Salary: $65,000 - $80,000 per year, depending on location and experience.



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