[Hiring] Clinical Study Administrator @Parexel

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

Company Description