Assistant CRA – FSP

Thermo Fisher Scientific

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

Posted 11/6/2026full-timeRemote • MexicoMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site management and remote monitoring within clinical trials, with a strong understanding of ICH GCP and regulatory guidelines. Proficient in document management, communication, and logistical support, ensuring compliance and efficiency in study operations.

Highest-signal resume keywords

Site ManagementRemote MonitoringICH GCP KnowledgeDocument Collection and ReviewEffective Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementMedical TerminologyData Extraction from Study DocumentsReconciliation of CRF and QueriesLogistical CoordinationVendor Qualification ProcessesStudy-Specific TrainingEMR/EHR ReviewAttention to DetailTime Management

Soft Skills

Interpersonal SkillsCustomer Service SkillsCritical ThinkingProblem-Solving SkillsFlexibility and Adaptability

Tools & Technologies

MS OfficeElectronic Study Data SystemsCTMSDashboards

Certifications & Qualifications

Bachelor's Degree in Life ScienceRegistered Nursing Certification

Industry Keywords

Oncology Clinical TrialsSOPsRegulatory GuidelinesStudy Management ActivitiesPatient-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 provide logistical support to 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/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 review of EMR/EHR checklists
Verify document collection and RCR submission status; update site EDL and site information
Review patient-facing materials and translations
Support site staff with vendor qualification processes
Support system access requests, grants, and revocations for site staff
Follow up on site staff training
Coordinate logistics for IM attendance
Maintain vendor trackers
Coordinate study/site supply management
Support essential document collection, review, and system updates
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 involving CRF and query status, deviations, SAEs, and safety reports
Verify document collection status and drive action on missing, incomplete, expired, or outstanding documents
Perform other assigned site management tasks and client-requested FSP role-profile tasks
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 providing the knowledge, skills, and abilities to perform the job, comparable to 0–2 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
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 information from study documents, electronic study data systems, CTMS, and dashboards
Excellent English language and grammar skills
Previous oncology clinical trial experience is highly desirable

Benefits

Comp & perks

Fully remote work arrangement
Standard Monday–Friday work schedule
Office or home office work environment
Occasional travel to clinics/hospitals may be required
Potential promotional opportunities in the CRA career track