Assistant CRA

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

• Complete study and site management activities per task matrix and study direction.
• Complete and document study-specific training; orient and train on study/CRG systems.
• Provide in-house support for pre-study assessments and assessment waivers (as agreed for 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 throughout study phases.
• 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 system updates (as applicable).
• 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, system updates, reconciliations, and follow-up on site invoices.
• Perform reconciliation tasks (e.g., CRF/query status, deviations, SAEs, safety reports) as applicable.
• Drive action on missing/incomplete/expired documents and open document findings in CRG systems.

• Education: Bachelor’s degree or higher in Life Sciences.
• Experience: Comparable to 0–1 year of experience providing the knowledge, skills, and abilities to perform the job.
• Licensing: Valid UK driving license.
• Knowledge: Basic medical/therapeutic area knowledge and medical terminology; ability to attain and maintain working knowledge of ICH GCP, applicable regulations, and procedural documents.
• Skills: Effective written and verbal communication; strong interpersonal and customer service skills; organization/time management and attention to detail; flexibility and adaptability; ability to work independently and in teams; critical thinking and root-cause problem solving.
• Technical: Proficient computer skills including MS Office; ability to learn study software; ability to extract information from study documents, electronic data systems, CTMS, and dashboards.
• Language: Excellent English language and grammar skills.

• Schedule: Standard (Mon–Fri).
• Work environment: Office.
• Location scope: UK (multiple locations mentioned).
• Other: Role includes remote activities in liaison with Remote CRA, On-Site CRA, and CTM; may include limited site contact activities across study phases.