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Assistant CRA – FSP
Thermo Fisher Scientific. Perform remote activities on assigned clinical research 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 clinical research project management, including site management, remote monitoring, and adherence to regulatory guidelines. Proficient in document management, communication, and collaboration within clinical study environments.
Highest-signal resume keywords
Clinical Research Project ManagementOncology Clinical Studies ExperienceICH GCP KnowledgeEffective Communication SkillsDocument Management and Reconciliation
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 MonitoringMedical TerminologyDocument CollectionData ExtractionCRF ReconciliationStudy-Specific TrainingVendor QualificationEMR/EHR ReviewCTMS Knowledge
Soft Skills
Interpersonal SkillsOrganizational SkillsTime ManagementCritical ThinkingProblem-Solving
Tools & Technologies
MS OfficeElectronic Study Data SystemsDashboards
Certifications & Qualifications
Bachelor's Degree in Life ScienceRegistered Nursing Certification
Industry Keywords
Clinical ResearchOncologySOPsRegulatory GuidelinesStudy Coordinator
About the role
Key responsibilities & impact- Perform remote activities on assigned clinical research projects in liaison with the CRA and study Clinical Lead
- Support site preparedness and monitoring logistics
- 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 users on study-specific systems
- Provide in-house support for pre-study assessments and waivers
- Customize site informed consent forms with site contact details as needed
- Perform remote review of EMR/EHR checklists
- Verify document collection, RCR submission status, site EDL, and site information
- Review patient-facing materials and translations
- Support vendor qualification, system access, site staff training, and IM attendance logistics
- Maintain vendor trackers and coordinate study/site supply management
- Support essential document collection, review, and system updates
- Follow up on missing vendor data, including ECGs, lab samples, and e-diaries
- Support ongoing remote review of centralized monitoring tools
- Coordinate site payment processes, system updates, reconciliations, and site invoice follow-up
- Perform reconciliation tasks for CRFs, queries, deviations, SAEs, and safety reports
- Drive action for missing, incomplete, or expired documents and open document findings
- Perform other assigned site management tasks and FSP-specific role profiles
- Complete administrative tasks including 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
- Previous experience in oncology clinical studies is required, preferably in roles such as CTC, PSC, or Study Coordinator
- 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
- 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, attention to detail, and ability to handle multiple tasks efficiently
- Flexibility and adaptability
- Ability to work independently or as part of a team
- 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 language and grammar skills
- Ability to work in an office or home office environment; occasional travel to clinics/hospitals may be required
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 with a global team and support clinical trials for leading pharmaceutical and biotechnology companies