Assistant CRA

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

• Perform remote study and site management activities per task matrix in liaison with Remote CRA, On-Site CRA, and CTM.
• Complete and document study-specific training; orient and train on study/CRG systems.
• Provide in-house support for pre-study assessments and related waivers as agreed for the project.
• Support customization of site ICF with site contact details.
• Conduct remote review of EMR/EHR checklists and support collection activities as applicable.
• 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 study system access is requested/granted/revoked for relevant site staff during pre-activation and the study.
• Follow up on site staff training completion as applicable.
• Coordinate logistics for IM attendance as directed; maintain vendor trackers as directed.
• Coordinate study and site supply management during pre-activation and throughout the study.
• Support essential document collection, review, and updates within relevant systems.
• Follow up on missing vendor data (e.g., ECGs, lab samples, e-diaries) and support remote review of centralized monitoring tools.
• Support site payments by coordinating with internal functions and sites; perform system updates/reconciliations and follow up on invoices.
• Perform reconciliation tasks (e.g., CRF/query status, deviations, SAEs, safety reports) as applicable.
• Drive actions for missing/incomplete/expired documents and resolve open document findings as directed.

• Education: Bachelor’s degree or higher in Life Sciences.
• Experience: Prior experience comparable to 0–1 year providing knowledge/skills to perform the role.
• License: Valid UK driving license.
• Clinical/Regulatory: Basic medical/therapeutic area knowledge; ability to attain and maintain working knowledge of ICH GCP, applicable regulations, and procedural documents.
• Skills: Strong written and verbal communication; excellent English grammar; interpersonal and customer service skills; organization/time management; attention to detail; flexibility/adaptability; ability to work independently or in a team; critical thinking and problem solving/root cause analysis.
• Technical: Proficient computer skills including MS Office; ability to learn new software; ability to extract key information from study documents and electronic systems (e.g., CTMS/dashboards).

• Schedule: Standard (Mon–Fri).
• Environment: Office.
• Location scope: Roles available across a range of locations in the UK.
• Employer notes: Thermo Fisher Scientific is an EEO/Affirmative Action Employer.