Clinical Research Associate

hace 6 horas


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 ensuring the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

", "Key Responsibilities": "
  • Perform site monitoring visits to evaluate the quality and integrity of study site practices.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites.
  • Manage 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.
  • Ensure copies/originals of site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  • Collaborate and liaise with study team members for project execution support as appropriate.
", "Qualifications": "
  • High School Diploma or equivalent Degree in scientific discipline or health care preferred.
  • Requires at least 1 year of on-site monitoring experience.
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
  • Good therapeutic and protocol knowledge as provided in company training.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • 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 Novasyte and our mission to create a healthier world.

", "Contact Us": "

Contact us to learn more about this opportunity.

", "Language": "English"}

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