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Thermo Fisher ScientificCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in study and site management activities, including document collection, vendor qualification processes, and compliance with ICH GCP regulations. Possesses strong communication skills in both French and English, along with effective organizational and problem-solving abilities.
Highest-signal resume keywords
Study ManagementICH GCP KnowledgeDocument Collection and ReviewEffective Communication SkillsVendor Qualification Processes
About the role
Key responsibilities & impact- Complete study and site management activities as defined in the task matrix
- Complete and document study-specific training
- Orient and train on study-specific systems
- Provide in-house support during pre-study assessments and waiver processes
- Customize site informed consent forms with site contact details as needed
- Perform remote review of EMR/EHR checklists
- Verify document collection and RCR submission status; update site EDL and verify site information
- Review patient-facing materials and translations
- Support site staff with vendor qualification processes
- Coordinate system access for relevant site staff
- Follow up on site staff training
- Coordinate logistics for investigator meeting attendance
- Maintain vendor trackers
- Coordinate study/site supply management
- Support essential document collection, review and updating in systems
- Follow up on missing vendor data such as 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 CRF and query status, 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-specific FSP role activities
- Complete expense reports and timesheets in a timely manner
- Liaise with the CRA and study Clinical Lead on assigned projects
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 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
- Ability to extract pertinent information from study documents, electronic study data systems, CTMS and dashboards
- Excellent French and English language and grammar skills
Benefits
Comp & perks- Remote activities on assigned projects
- Hybrid work arrangement
- Standard Monday-Friday work schedule
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study Management ActivitiesDocument CollectionMedical TerminologyElectronic Data SystemsCTMS KnowledgeRemote Review of EMR/EHRReconciliation TasksTraining and OrientationExpense ReportingTimesheet Management
Soft Skills
Interpersonal SkillsOrganizational SkillsTime ManagementCritical ThinkingFlexibility and Adaptability
Tools & Technologies
MS OfficeCentralized Monitoring ToolsVendor TrackersStudy-Specific Systems
Certifications & Qualifications
Bachelor's Degree in Life ScienceRegistered Nursing Certification
Industry Keywords
Clinical ResearchSite ManagementPatient-Facing MaterialsRegulatory ComplianceStudy-Specific Training