Assistant CRA

Thermo Fisher Scientific

. Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead .

Posted 9/29/2026full-timeRemote • RomaniaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates proficiency in site management and remote monitoring tasks, with a strong understanding of ICH GCP and regulatory guidelines. Capable of effective communication, organization, and problem-solving in a clinical research environment.

Highest-signal resume keywords

Site ManagementICH GCP KnowledgeClinical Research ExperienceEffective Communication SkillsAttention to Detail

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site ICF CustomizationDocument Collection VerificationEMR/EHR Checklist ReviewsStudy-Specific TrainingReconciliation of CRFsData Extraction from Study DocumentsLogistical Support CoordinationVendor Qualification ProcessesStudy Supply ManagementAdministrative Task Management

Soft Skills

Interpersonal SkillsCustomer Service SkillsOrganizational SkillsTime Management SkillsCritical Thinking

Tools & Technologies

MS OfficeElectronic Study Data SystemsCTMSDashboards

Certifications & Qualifications

Bachelor's Degree in Life ScienceRegistered Nursing Certification

Industry Keywords

Clinical TrialsRegulatory GuidelinesSOPsMedical TerminologyTherapeutic Area Knowledge

About the role

Key responsibilities & impact

Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead
Support site preparedness and provide logistical support to the monitoring process
Assist with site management and remote monitoring tasks in accordance with SOPs and regulatory guidelines
Complete study and site management activities defined in the task matrix
Complete and document study-specific training and learn study-specific systems
Provide in-house support during pre-study assessments and waivers
Customize Site ICF with site contact details as needed
Perform remote EMR/EHR checklist reviews
Verify document collection and RCR submission status; update site EDL and site information
Review patient-facing materials and translations
Support vendor qualification processes and site staff system access
Follow up on site staff training
Coordinate logistics for IM attendance and maintain vendor trackers
Coordinate study/site supply management
Support Essential Document collection, review and updating
Follow up on missing vendor data including ECGs, lab samples and e-diaries
Support remote review of centralized monitoring tools
Support site payment processes, system updates, reconciliations and invoice follow-up
Perform reconciliation tasks for CRFs, queries, deviations, SAEs and safety reports
Verify document collection status and drive action on missing or incomplete documentation
Perform other assigned site management tasks and FSP role profiles as directed
Complete administrative tasks including expense reports and timesheets

Requirements

What you’ll need

Bachelor's degree in a life science discipline or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
Previous experience comparable to 0 to 2 years
An equivalency combining appropriate education, training and/or directly related experience may be considered sufficient
Basic medical/therapeutic area knowledge and understanding of medical terminology
Working knowledge of ICH GCP, applicable regulations and company procedural documents
Effective oral and written communication skills
Excellent interpersonal and customer service skills
Good organizational and time management skills and strong attention to detail
Proven ability to handle multiple tasks efficiently and effectively
Flexibility and adaptability
Ability to work in a team or independently
Critical thinking, root cause analysis and problem-solving skills
Proficient computer skills and good knowledge of MS Office
Ability to learn and use appropriate software and leverage modern technology
Ability to extract pertinent information from study documents, electronic study data systems, CTMS and dashboards
Excellent English language and grammar skills

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday-Friday work schedule
Office or home office environment
Occasional travel to clinics/hospitals may be required