Assistant CRA

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

• Complete study and site management activities per task matrix and direction from the CRA/Clinical Lead.

• Complete and document study-specific training and learn study systems.

• Provide in-house support during pre-study assessments and support pre-study assessment waivers as agreed.

• Support customization of Site ICF with site contact details as needed.

• Perform remote review of EMR/EHR checklists and support collection activities 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 throughout the study.

• Follow up on site staff training as applicable.

• Coordinate 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 updating within systems 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, including coordination with internal functions and sites, system updates/reconciliations, and invoice follow-up.

• 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 company systems as directed.

• Perform other site management tasks as directed by the CRA and per task matrix; may support FSP role profiles per client requests.

• Complete administrative tasks such as expense reports and timesheets on time.

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

• Comparable experience level of 0–2 years (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 oral and written communication skills; excellent English language and grammar.

• Strong interpersonal and customer service skills.

• Good organizational and time management skills with strong attention to detail; ability to handle multiple tasks.

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

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

• Proficient computer skills including MS Office; ability to learn study software and extract information from study systems (e.g., CTMS/dashboards).

• Schedule: Standard (Mon–Fri).

• Environment: Office or home office; exposure to electrical office equipment.

• Travel: Occasional travel to clinics/hospitals may be required; the Assistant CRA role does not involve regular travel (note: CRA career track promotional opportunities may require frequent travel of 60–80%).

• Employer: Role promoted by Lensa on behalf of Thermo Fisher Scientific.