Clinical Study Administrator (CTA)

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

When our values align, there’s no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

Trial and Site Administration:

• Assists in coordination and administration of clinical studies from the start-up to execution and closeout.
• Serves as local administrative main contact and works closely with the CRAs and/or the Local Study Associate Director (LSAD) for the duration of the study.
• Sets-up, populates and accurately maintains information in Client tracking and communication tools (e.g. CTMS such as VCV, SharePoint, etc.) and supports others in the usage of these systems (except for countries where there is a specific role dedicated to set up and update the systems).
• Manages and contributes to coordination and tracking of study materials and equipment.
• Coordinates administrative tasks during the study process, audits, and regulatory inspections, according to company policies and SOPs.
• Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings.
• Liaises with internal and external participants and/or vendors, in line with international and local codes.
• Prepares, contributes to, and distributes presentation material for meetings, newsletters, and websites.

Document Management:

• Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.

• Operational responsibility for the correct set-up and maintenance of the local electronic Trial Master File (eTMF) and Investigator Site File (ISF) including document tracking in accordance with ICH-GCP and local requirements.

• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.

• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.

• Contributes to the production and maintenance of study documents, ensuring template and version compliance.

• Responsible for layout and language control, copying and distribution of documents. Supports with local translation and spell checks in English to/from local language, as required.

• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.

• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.

Regulatory and Site Start Up Responsibilities:

• Collects, assists in preparation, reviews, and tracks documents for the application process.

• Assists in timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities for the duration of the study.

• Creates and/or imports clinical-regulatory documents into the Global Electronic Management System (e.g. ANGEL) ensuring compliance with the Client’s Authoring Guide for Regulatory Documents.

• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.

Budgeting, Agreements and Payments:

• Prepares and/or supports contract preparation at a site level (except for countries where there is a specific role dedicated to preparing site contracts).

• Prepares/supports/performs Health Care Organizations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.