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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 expertise in site management and remote monitoring processes, with a strong understanding of ICH GCP and regulatory guidelines. Proficient in document collection, study-specific training, and effective communication within clinical research environments.
Highest-signal resume keywords
Site ManagementICH GCP KnowledgeDocument Collection and ReviewEffective Communication SkillsCritical Thinking and Problem-Solving
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site ManagementRemote MonitoringDocument CollectionStudy-Specific TrainingMedical TerminologyRegulatory ComplianceData ExtractionCTMS KnowledgeEMR/EHR ReviewReconciliation Tasks
Soft Skills
Interpersonal SkillsCustomer Service SkillsOrganizational SkillsTime ManagementFlexibility and Adaptability
Tools & Technologies
MS OfficeElectronic Study Data SystemsDashboardsVendor Trackers
Certifications & Qualifications
Bachelor's Degree in Life ScienceRegistered Nursing Certification
Industry Keywords
Clinical ResearchSOPsStudy Start-UpPatient-Facing MaterialsVendor 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 tasks in accordance with SOPs and regulatory guidelines
- Perform limited site contact activities during study start-up, site management, recruitment, and close-out phases
- 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 for pre-study assessments and waivers
- Customize Site ICFs with site contact details as needed
- Perform remote EMR/EHR checklist reviews and support assessments
- Verify document collection and RCR submission status; update site EDL and site information
- Review patient-facing materials and translations
- Support vendor qualification, system access, site staff training, IM attendance, 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
- 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, incomplete, or expired documents
- Perform other assigned site management tasks and client-requested FSP role profiles
- 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 relevant formal academic/vocational qualification
- Previous experience comparable to 0 to 2 years
- Equivalent 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 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 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
- Standard Monday–Friday work schedule
- Home office environment
- Occasional travel to clinics/hospitals may be required
- Opportunity to work on projects supporting leading pharmaceutical companies and biotechs
- Career-track promotional opportunities