Overview

Senior Clinical Study Administrator - Hybrid (Remote/Office-based), Luton, UK - FSP

Parexel is currently registering interest for Senior Clinical Study Administrators (Sr CSA) for future opportunities for hybrid remote/office-based roles in Luton, UK. These roles will be assigned to one of our key sponsors and operate from their site in the Luton area for up to 3 days/week.

Responsibilities

• 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 trial managers for the duration of the study.
• Sets up, populates and accurately maintains information in client tracking tools (e.g., CTMS such as VCV, SharePoint) 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 practical arrangements and contributes to the preparation of internal and external 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. 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.
• 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.

Regulatory And Site Start Up

• 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, 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 Authoring Guide for Regulatory Documents.
• Contributes to electronic applications/submissions by handling clinical regulatory documents according to the requested technical standards (Submission Ready Standards - SRS).

Budgeting, Agreements And Payments

• Prepares and/or supports contract preparation at a site level.
• Prepares/supports Health Care Organizations (HCO) / Health Care Professionals (HCP) payments in accordance with local regulations.

Qualifications

• High school/Secondary school qualifications (or equivalent) relevant to the position.
• Proven organisational and administrative skills.
• IT proficiency.
• Fluent in written and spoken English.
• Previous administrative experience, preferably in the medical/life sciences field.
• Knowledge of the Clinical Study Process and familiarity with ICH-GCP guidelines is preferred.
• Good verbal and written communication, strong interpersonal skills, and ability to work in an international team.
• Willingness and ability to train others on study administration procedures.
• Excellent organization and time management skills with attention to detail.
• Ability to multi-task in a high-volume environment with shifting priorities.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Integrity and high ethical standards.

We care about our people and their development, offering an open and friendly work environment with opportunities to grow within Parexel and in related departments. Not quite the role for you? Join our Talent Community to receive job alerts when matching positions become available.