Assistant CRA

PPD, part of Thermo Fisher Scientific, is hiring Assistant Clinical Research Associates (ACRAs) across the UK to support end-to-end clinical trial operations. The role focuses on remote study and site management activities, supporting monitoring logistics and ensuring compliance with SOPs and regulatory guidelines.

• Complete study and site management activities per task matrix and project direction.

• Complete and document study-specific training; orient and train on study/CRG systems.

• Provide in-house support for pre-study assessments and waivers as agreed for the project.

• Support customization of Site ICF with site contact details as needed.

• Perform remote review of EMR/EHR checklists and support collection of applicable assessments.

• Verify document collection and RCR submission status; update site EDL and verify site information.

• Review patient-facing materials and translations as directed.

• Support site staff with vendor-related qualification processes where applicable.

• Ensure system access is requested/granted/revoked for relevant site staff during pre-activation and throughout the study.

• Follow up on site staff training as applicable.

• Coordinate and support logistics for IM attendance as directed.

• Maintain vendor trackers as directed.

• Coordinate study/site supply management during pre-activation and throughout the study.

• Support Essential Document collection, review, and updates within systems.

• Follow up on missing vendor data (e.g., ECGs, lab samples, e-diaries) as directed.

• Support ongoing remote review of centralized monitoring tools as directed.

• Support site payment processes by coordinating with internal functions and sites; support system updates/reconciliations and follow up on invoices.

• Perform reconciliation tasks including CRF/query status, deviations, SAEs, and safety reports as applicable.

• Drive actions for missing/incomplete/expired documents and open document findings within CRG systems.

• Bachelor's degree or higher in Life Sciences.

• Previous experience comparable to 0 to 1 year.

• Valid UK driving license.

• Basic medical/therapeutic area knowledge and understanding of medical terminology.

• Ability to attain and maintain working knowledge of ICH GCP, applicable regulations, and procedural documents.

• Effective written and oral communication skills; excellent English language and grammar.

• Excellent interpersonal and customer service skills.

• Strong organizational and time management skills; attention to detail; ability to handle multiple tasks.

• Flexibility and adaptability; ability to work independently or in a team.

• Critical thinking skills, including investigation, root cause analysis, and problem solving.

• Proficient computer skills including MS Office; ability to learn study software; ability to extract information from study documents, electronic systems, CTMS, and dashboards.

• Work schedule: Standard (Mon-Fri).

• Environmental conditions: Office.

• Location scope: UK (multiple locations).