Assistant CRA

Position Overview

• Location Type: Not Specified
• Job Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office
• Location: United Kingdom

PPD, part of Thermo Fisher Scientific, is hiring experienced Assistant Clinical Research Associates (ACRAs) across the UK. Thermo Fisher Scientific is dedicated to enabling customers to make the world healthier, cleaner, and safer through meaningful work that has a positive global impact. The company provides resources for individual career goals and advances science through research, development, and delivery of life-changing therapies. With clinical trials in over 100 countries and ongoing development of novel frameworks for clinical research, their work spans laboratory, digital, and decentralized clinical trial services. The ACRA role contributes to improving health outcomes through quality and accuracy in clinical studies.

The Clinical Operations team within PPD clinical research services offers end-to-end support for clinical trials, from study start-up to monitoring and close-out. They help clients define and develop clinical programs, minimize delays, and implement high-quality, cost-efficient studies.

Responsibilities

The ACRA performs remote activities in liaison with the Remote CRA, On-Site CRA, and study CTM. Key responsibilities include:

• Providing support with site preparedness and logistical aspects of the monitoring process.
• Assisting with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines.
• May undertake limited site contact activities during study start-up, site management, recruitment, and close-out phases.

A day in the life includes:

• Completing study and site management activities as defined in the task matrix and directed for assigned studies.
• Completing and documenting study-specific training.
• Orienting and training on CRG/study-specific systems.
• Providing in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for the project.
• Supporting the customization of Site ICF with site contact details, as needed.
• Performing remote review of EMR/EHR checklists and supporting collection, as applicable.
• Verifying document collection and RCR submission status; updating site EDL and verifying site information.
• Reviewing patient-facing materials and translations, as directed.
• Supporting site staff with the vendor qualification process, where applicable.
• Ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and throughout the study.
• Supporting follow-up on site staff training, as applicable.
• Coordinating and supporting logistics for IM attendance, as directed.
• Supporting the maintenance of vendor trackers, as directed.
• Coordinating study/site supply management during pre-activation and throughout the study.
• Supporting Essential Document collection, review, and updating in systems, as applicable.
• Following up and supporting on missing study vendor data (e.g., ECGs, lab samples, e-diaries), as directed.
• Supporting ongoing remote review of centralized monitoring tools, as directed.
• Supporting site payment processes by coordinating with various functional departments and sites.
• Supporting system updates and reconciliations, as directed, and following up on site invoices throughout the study period.
• Performing reconciliation tasks on assigned trials, including CRF and query status, deviations, SAEs, and safety reports, as applicable.
• Verifying documentation.

Requirements

• Experienced Assistant Clinical Research Associate.