Clinical Trial Submissions Coordinator

FTPHP Fortrea Philippines Inc.; Manila; On-site; PHP 360,000 - 600,000; Full time

Job summary

Fortrea Philippines Inc. seeks a Regulatory Submissions Coordinator to act as primary contact with investigative sites during study maintenance and site startup activities, ensuring timely collection and quality review of essential documents for RA/IRB/IEC submissions.

You will work under supervision to ensure compliance with ICH/GCP, SOPs, and local regulations, coordinate with vendors, and support submission preparation for audits.

Qualifications

• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.

Responsibilities

• Serve as primary contact for investigative sites and ensure documents are collected in a timely manner.
• Compile, prepare, submit, and obtain approval of submission documents to IRB/IEC/Regulatory Authority.
• Coordinate with internal and external vendors for Regulatory Authority submissions and perform quality review of final documents.
• Assist in updating study documents and ensuring readiness for audits when needed.

Skills

ICH/GCP knowledge

IRB/IEC familiarity

Regulatory submissions

Documentation quality review

Education

University/College degree (life science preferred) or allied health certification

Job description

Fortrea Philippines Inc. seeks a Regulatory Submissions Coordinator to act as primary contact with investigative sites during study maintenance and site startup activities, ensuring timely collection and quality review of essential documents for RA/IRB/IEC submissions.

You will work under supervision to ensure compliance with ICH/GCP, SOPs, and local regulations, coordinate with vendors, and support submission preparation for audits.