Clinical Trials Operations Coordinator

hace 1 mes

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

Company Overview:

Worldwide Clinical Trials (WCT) is a leading global contract research organization that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications.

The company has a dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, which enables them to develop flexible plans and solve problems quickly for their customers.

Job Summary:

We are seeking an experienced Clinical Assessment Operations Associate to join our team. The successful candidate will be responsible for carrying out daily operational work related to rater selection, certification, training content, scale acquisition, surveillance maintenance, and workbook/source document management.

The role involves ensuring all assigned projects are conducted in a timely fashion and in compliance with SOPs and ICH/GCP/regulatory guidelines.

About the Role:

This is an exciting opportunity to work as part of a dynamic team that is united in its commitment to improving the lives of patients through innovative therapies.

The successful candidate will have a strong background in clinical trials operations and experience working with data and numbers.

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 and format materials such as rater training documents, Excel spreadsheets, PowerPoint slides, and Microsoft Word
  • Conduct scale management activities, including 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 document

What You Will Bring:

  • A highly organized, detail-oriented, and service-focused individual
  • Excellent written and verbal communication skills
  • Ability to work effectively under pressure and manage multiple tasks
  • High level of interpersonal skills in a fast-paced, deadline-oriented environment
  • Strong self-motivation and ability to work in teams

Your Background:

  • Possess a minimum of an Associate's degree
  • Have at least 1+ years of clinical trial experience
  • Demonstrate knowledge of operational aspects of Phase I-IV clinical trials
  • Be familiar with SOPs and ICH/GCP/regulatory guidelines
  • Competent in working with data and numbers

Salary and Benefits:

$60,000 - $80,000 per year, depending on experience

This role offers a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.

Language:

This position requires fluency in English, both written and spoken, as it involves working with international clients and partners.

Travel:

The role may require travel domestically and internationally to attend key meetings and collaborate with stakeholders in different time zones.

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