Study Start Up Coordinator

hace 3 días


Ciudad de México, Ciudad de México CTI Clinical Trial and Consulting Services A tiempo completo
Regulatory Affairs, Study Start Up Specialist II

Company Overview:

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.

Job Description:

This role involves assisting project teams with regulatory requirements for clinical studies. The successful candidate will have excellent communication skills and be able to work well in a team environment.

Responsibilities:

  • Assist/advise project teams on all regulatory requirements for clinical studies.
  • Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings.
  • Review and adapt study specific documents according to each country and site requirements.
  • Perform IRB/EC (CA) and/or other Regulatory Bodies submissions on behalf of sponsors and/or sites as agreed with the Sponsor and in accordance with each country requirements.

Requirements:

  • Associate or Bachelor's degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
  • At least 3-5 years of relevant pharmaceutical, site, or CRO Regulatory experience.
  • Experience in Clinical Trials Submissions in several LATAM countries.
  • Strong working knowledge and understanding of FDA, Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) regulations and guidelines.

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