Assistant CRA

PPD, part of Thermo Fisher Scientific, is hiring Assistant Clinical Research Associates (ACRAs) in the UK to support end-to-end delivery of clinical trials. The role focuses on remote study and site management activities, ensuring site preparedness, document compliance, and operational support across study phases in accordance with SOPs and regulatory guidelines.

• Perform remote study and site management activities per task matrix and study assignment.

• 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 when needed.

• Conduct 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 appropriate system access is requested/granted/revoked for relevant site staff 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 in 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 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.

• Bachelor's degree or higher in Life Sciences.

• Prior experience comparable to 0–1 year providing knowledge/skills to perform the role.

• Valid UK driving license.

• Basic medical/therapeutic area knowledge and medical terminology.

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

• Effective written and verbal communication; excellent English language and grammar.

• Strong interpersonal and customer service skills.

• Organizational and time management skills; attention to detail; ability to manage multiple tasks.

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

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

• Proficient computer skills including MS Office; ability to learn study software and use modern technology.

• Ability to extract pertinent information from study documents and electronic systems (e.g., CTMS, dashboards).

• Work schedule: Standard (Mon–Fri).

• Environmental conditions: Office.

• Location: UK (multiple locations); remote activities included.

• Employer: PPD, part of Thermo Fisher Scientific.

• Equal Opportunity Employer statement provided.