Clinical Trials Operations Coordinator

Parexel; United States; Remote; USD 50,000 - 85,000; Full time

Job summary

Parexel is seeking an organized Trial and Site Administration professional in the United States to support administrative tasks across clinical studies from start-up to closeout. The role involves coordinating with CRAs, LSAD, and vendors, managing documentation, and ensuring compliance with ICH-GCP and local requirements.

The candidate will handle eTMF/ISF maintenance, meeting preparations, and regulatory submissions, contributing to efficient trial execution and inspections readiness.

Responsibilities

• Assist coordination and administration of clinical studies from start-up to closeout.
• Serve as local administrative contact with CRAs and LSAD for the study.
• Set up and maintain information in CTMS and related tools.
• Manage study materials and equipment coordination.
• Coordinate study tasks during audits and inspections per SOPs.
• Lead arrangements for internal/external meetings.
• Liaise with participants and vendors per international/local codes.
• Prepare and distribute meeting materials and newsletters.
• Interface with investigators and CRAs to support document delivery.
• Maintain eTMF and ISF setup per ICH-GCP and local rules.
• Upload essential documents to keep eTMF ready for inspections.
• Ensure documents are archived and assist ISF close-out.
• Ensure template/version compliant study documents.
• Oversee document layout, translation, and spell checks.
• Print and distribute letters and meeting minutes; archive emails.
• Coordinate with Data Management to deliver study materials.
• Collect and prepare documents for regulatory submissions.
• Submit to EC/IRB and authorities as needed.
• Create/import documents into the eTMF systems.
• Support electronic submissions using SRS standards.
• Assist in site contracts and budget preparation.
• Process HCO/HCP payments per local rules.

Job description

Parexel is seeking an organized Trial and Site Administration professional in the United States to support administrative tasks across clinical studies from start-up to closeout. The role involves coordinating with CRAs, LSAD, and vendors, managing documentation, and ensuring compliance with ICH-GCP and local requirements.

The candidate will handle eTMF/ISF maintenance, meeting preparations, and regulatory submissions, contributing to efficient trial execution and inspections readiness.