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Clinical Research Associate

hace 2 meses

Xico, México Novasyte A tiempo completo
{"Job Overview": "

At Novasyte, we are seeking a skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for performing site monitoring visits, administering protocol and related study training, and evaluating the quality and integrity of study site practices.

", "Responsibilities": "

Key responsibilities include:

  • Performing site monitoring visits to ensure compliance with contracted scope of work and regulatory requirements
  • Administering protocol and related study training to assigned sites
  • Evaluating the quality and integrity of study site practices
  • Managing the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
  • Ensuring copies/originals of site documents are available for filing in the Trial Master File (TMF) and verifying that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements
  • Creating and maintaining appropriate documentation regarding site management, monitoring visit findings and action plans
", "Requirements": "

To be successful in this role, you will need:

  • A Bachelor's Degree in a scientific discipline or healthcare preferred
  • At least 3 years of on-site monitoring experience
  • Equivalent combination of education, training and experience may be accepted in lieu of degree
  • In-depth knowledge of and skill in applying applicable clinical research regulatory requirements
  • Strong therapeutic and protocol knowledge as provided in company training
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
  • Written and verbal communication skills including good command of English language
  • Organizational and problem-solving skills
  • Effective time and financial management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients
", "About Us": "

Novasyte is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.

", "Learn More": "

Learn more about our company and our mission to create a healthier world.

"}