Assistant CRA

Thermo Fisher Scientific

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

Posted 9/17/2026full-timeRemote • Texas • United StatesMid-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 management, communication, and organizational skills to support clinical study activities effectively.

Highest-signal resume keywords

Site ManagementICH GCP KnowledgeDocument Collection and ReviewEffective Communication SkillsCritical Thinking and Problem-Solving

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study ManagementMedical TerminologyRegulatory ComplianceData Extraction from Study DocumentsRemote Monitoring Tasks

Soft Skills

Interpersonal SkillsOrganizational SkillsTime ManagementFlexibility and AdaptabilityTeam Collaboration

Tools & Technologies

MS OfficeElectronic Study Data SystemsCTMSDashboards

Certifications & Qualifications

Bachelor's Degree in Life ScienceRegistered Nursing Certification

Industry Keywords

Clinical ResearchSite PreparednessVendor QualificationEssential Document CollectionPatient-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 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 orient to 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 EMR/EHR checklist reviews and support applicable assessments
Verify document collection and RCR submission status; update site EDL and site information
Review patient-facing materials and translations
Support vendor qualification, site-system access, site staff training, IM attendance logistics, vendor trackers and study/site supplies
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
Coordinate site payments, system updates, reconciliations and site invoice follow-up
Perform reconciliation tasks involving CRF and query status, deviations, SAEs and safety reports
Drive action for missing, incomplete or expired documents and open document findings
Perform other assigned site management tasks and client-requested FSP role profiles
Complete administrative tasks including expense reports and timesheets
Occasional travel to clinics or hospitals may be required

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
Previous experience comparable to 0 to 2 years
Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
Basic medical/therapeutic area knowledge and understanding of medical terminology
Working knowledge of ICH GCP, applicable regulations and company procedural documents, or ability to attain and maintain it
Effective oral and written communication skills
Excellent interpersonal and customer service skills
Good organizational and time management skills and strong attention to detail
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 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
Work performed in an office or home office environment
Standard Monday–Friday work schedule
Opportunity to work with a global team
Potential career-track opportunities in Clinical Research Associate roles