Assistant CRA

Thermo Fisher Scientific is hiring an Assistant Clinical Research Associate (Assistant CRA) to support global clinical trial operations across assigned studies. The role focuses on remote site preparedness, study/site management, and logistical support to monitoring activities in alignment with SOPs and regulatory guidelines.

• Complete study and site management activities per the task matrix and document study-specific training.

• Orient to and support use of study-specific systems.

• Provide in-house support for pre-study assessments and waivers (as applicable).

• Support customization of Site ICF with site contact details.

• Perform remote review of EMR/EHR checklists and support related collection activities.

• Verify document collection and RCR submission status; update site EDL and verify site information.

• Review patient-facing materials and translation reviews as directed.

• Support site staff with vendor qualification processes where applicable.

• Ensure system access is requested/granted/revoked for site staff across study phases.

• Follow up on site staff training requirements as applicable.

• Coordinate logistics for IM attendance and maintain vendor trackers as directed.

• Coordinate study/site supply management during pre-activation and throughout the study.

• Support essential document collection, review, and updating in company systems.

• Follow up on missing study vendor data (e.g., ECGs, lab samples, e-diaries).

• Support ongoing remote review of centralized monitoring tools.

• Support site payment processes, system updates, reconciliations, and site invoice follow-up.

• Perform reconciliation tasks (e.g., CRF/query status, deviations, SAEs, safety reports) as applicable.

• Drive action for missing/incomplete/expired documents and open document findings.

• Complete administrative tasks such as expense reports and timesheets.

• Bachelor’s degree in a life science discipline or related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification.

• 0–2 years of relevant experience (or equivalent combination of education, training, and directly related experience).

• Basic medical/therapeutic area knowledge and understanding of medical terminology.

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

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

• Strong interpersonal and customer service skills; ability to work independently or within a team.

• Strong organization, time management, attention to detail, flexibility, and adaptability.

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

• Proficient computer skills including MS Office; ability to learn study software and use CTMS/dashboards to extract pertinent information.

• Schedule: Standard (Mon–Fri).

• Environment: Office/home office; work performed most of the time in an office or home office environment.

• Occasional travel to clinics/hospitals may be required.

• Role does not involve regular travel; future CRA track opportunities may require frequent travel (60–80%).