Study Start Up Coordinator
hace 3 días
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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