Lensa
Assistant CRA
Summary
PPD, part of Thermo Fisher Scientific, is hiring experienced 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, ensuring site preparedness, document completeness, and compliance with SOPs and regulatory guidelines.
What you'll do
- Complete study and site management activities per the task matrix and study direction.
- Complete and document study-specific training; orient and train on CRG/study systems.
- Provide in-house support for pre-study assessments and applicable waivers.
- Support customization of Site ICF with site contact details.
- 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 across the study lifecycle.
- 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.
- Follow up on missing vendor data (e.g., ECGs, lab samples, e-diaries) as directed.
- Support ongoing remote review of centralized monitoring tools.
- 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 actions for missing/incomplete/expired documents and open document findings in CRG systems.
Requirements
Education: Bachelor’s degree or higher in Life Sciences.
Experience: Comparable to 0–1 year of relevant experience providing the knowledge, skills, and abilities to perform the job.
Licenses: 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 CRG procedural documents.
Skills: Effective written and verbal communication; excellent English language and grammar; strong interpersonal/customer service skills; organization, time management, attention to detail; flexibility and adaptability; ability to work independently or in a team; critical thinking and root cause/problem solving; proficient computer skills (MS Office) and ability to learn study software; ability to extract information from study documents, electronic study systems, CTMS, and dashboards.
Conditions
Schedule: Standard (Mon–Fri).
Environment: Office.
Location scope: Roles available across a range of UK locations; remote activities are a core part of the position.
Employer: PPD, part of Thermo Fisher Scientific (posted/promoted via Lensa).