Assistant CRA

Thermo Fisher Scientific

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

Posted 11/5/2026full-timeRemote • GermanyMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site management and remote monitoring, with a strong understanding of ICH GCP and regulatory guidelines. Proficient in document collection, patient-facing materials review, and effective communication in English and German.

Highest-signal resume keywords

Site ManagementICH GCP KnowledgeDocument Collection and ReviewEffective Communication SkillsProficient in MS Office

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site ManagementRemote MonitoringDocument CollectionMedical TerminologyCritical ThinkingRoot Cause AnalysisProblem-SolvingStudy-Specific TrainingTrial ReconciliationVendor Qualification

Soft Skills

Interpersonal SkillsCustomer Service SkillsOrganizational SkillsTime ManagementFlexibility

Tools & Technologies

Electronic Study Data SystemsCTMSDashboardsMS Office

Certifications & Qualifications

Bachelor's Degree in Life ScienceRegistered Nursing Certification

Industry Keywords

Clinical ResearchRegulatory GuidelinesSOPsStudy ManagementPatient-Facing Materials

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 training on study-specific systems
Provide in-house support during pre-study assessments and assessment waivers
Customize site ICFs with site contact details as needed
Perform remote review of EMR/EHR checklists and support applicable assessments
Verify document collection and RCR submission status; update site EDL and verify site information
Review patient-facing materials and translations
Support vendor qualification, system access, site staff training, IM attendance logistics, vendor trackers and study/site supply management
Support essential document collection, review and updating in systems
Follow up on missing vendor data including ECGs, lab samples and e-diaries
Support ongoing remote review of centralized monitoring tools
Support site payment processes, system updates, reconciliations and site invoice follow-up
Perform trial reconciliation tasks involving CRF and query status, deviations, SAEs and safety reports
Verify document collection status and drive action for missing, incomplete or expired documents and open findings
Perform other assigned site management tasks and client-requested FSP role profiles
Complete administrative tasks such as expense reports and timesheets
May perform limited site contact activities during study start-up, site management, recruitment and close-out phases

Requirements

What you’ll need

Bachelor's degree in a life science discipline or related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 2 years
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 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
Well-developed 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
Ability to extract pertinent information from study documents, electronic study data systems, CTMS and dashboards
Excellent English and German language and grammar skills

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule
Home office environment
Occasional travel to clinics/hospitals may be required
Opportunity to work with a global team at the forefront of clinical research innovation
Career progression opportunities into CRA roles (promotional opportunities may involve frequent travel)