Clinical Trials Start-Up Specialist

Fortrea; Sydney; Sur place; AUD 90 000 - 110 000; Plein temps

Résumé du poste

Fortrea is seeking a regulatory submissions specialist to act as the primary liaison with investigative sites. You will collect and compile essential documents, ensure timely IRB/IEC and authority submissions, and coordinate with internal teams and vendors to maintain project timelines.

The role requires knowledge of ICH/GCP, regulatory guidelines, and a proactive approach to risk escalation, with a focus on audit readiness and quality review.

Qualifications

• University/college degree in life sciences or related field or equivalent experience.
• Experience or certification in clinical trial regulation and submission processes.

Responsabilités

• Serve as primary contact with investigative sites for regulatory submissions.
• Prepare, compile, and submit documents to IRB/IEC/Regulatory Authorities.
• Coordinate with vendors and internal teams to ensure timely submissions.
• Review final submission documents for accuracy and compliance.
• Maintain communication and status updates across Fortrea projects.

Connaissances

Regulatory submissions

ICH/GCP knowledge

IRB/IEC familiarity

Quality review

Site coordination

Formation

Life science degree

Related certification

Description du poste

Fortrea is seeking a regulatory submissions specialist to act as the primary liaison with investigative sites. You will collect and compile essential documents, ensure timely IRB/IEC and authority submissions, and coordinate with internal teams and vendors to maintain project timelines.

The role requires knowledge of ICH/GCP, regulatory guidelines, and a proactive approach to risk escalation, with a focus on audit readiness and quality review.