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Assistant CRA
Thermo Fisher Scientific. Perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in site management and remote monitoring in compliance with SOPs and regulatory guidelines, with a strong foundation in medical terminology and ICH GCP. Capable of effective communication, critical thinking, and problem-solving while managing multiple tasks efficiently.
Highest-signal resume keywords
Site ManagementRemote MonitoringICH GCP KnowledgeEffective Communication SkillsCritical Thinking
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical TerminologySite ICF CustomizationDocument Collection VerificationReconciliation TasksStudy-Specific TrainingEMR/EHR Checklist ReviewsCTMS KnowledgeData ExtractionRegulatory ComplianceTime Management
Soft Skills
Interpersonal SkillsCustomer Service SkillsOrganizational SkillsFlexibilityAdaptability
Tools & Technologies
MS OfficeElectronic Study Data SystemsCentralized Monitoring ToolsVendor TrackersStudy/Site Supply Management Systems
Certifications & Qualifications
Bachelor's Degree in Life ScienceRegistered Nursing Certification
Industry Keywords
Clinical ResearchSOPsRegulatory GuidelinesStudy ManagementVendor Qualification
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 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/train 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 EMR/EHR checklist reviews 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 invoice follow-up
- Perform 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 specific FSP role profiles as directed
- Complete administrative tasks such as expense reports and timesheets
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
- 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 independently or in a team
- 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
- Home office environment
- Occasional travel to clinics/hospitals may be required