Lensa
Assistant CRA
Summary
PPD, part of Thermo Fisher Scientific, is hiring Assistant Clinical Research Associates (ACRAs) across the UK to support end-to-end clinical trial delivery. The role focuses on remote study and site management activities, supporting monitoring logistics and site preparedness in line with SOPs and regulatory guidelines.
What you'll do
Perform remote 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.
Support customization of site ICF with site contact details as needed.
Conduct remote review of EMR/EHR checklists and support collection/assessments 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 system access is requested/granted/revoked for relevant site staff during pre-activation and study conduct.
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 in relevant 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, system updates/reconciliations, and follow up on site invoices.
Perform reconciliation tasks including CRF/query status, deviations, SAEs, and safety reports as applicable.
Drive action on missing/incomplete/expired documents and open document findings in CRG systems as directed.
Requirements
Bachelor's degree or higher in Life Sciences.
Previous experience comparable to 0 to 1 year providing the knowledge, skills, and abilities to perform the job.
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 CRG procedural documents.
Effective oral and written 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 within a team.
Critical thinking skills including root cause analysis and problem solving.
Proficient computer skills including MS Office; ability to learn and use appropriate clinical systems.
Ability to extract pertinent information from study documents and electronic systems (e.g., CTMS, dashboards).
Conditions
Schedule: Standard (Mon-Fri).
Environmental conditions: Office.
Location scope: Multiple locations across the UK.
Employment context: Role advertised via Lensa; employment is with Thermo Fisher Scientific/PPD (per posting).