Assistant CRA

🔥 21 minutes ago

🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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 • 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 • Orient and train on study-specific systems • Provide in-house support during pre-study assessments and pre-study assessment waivers • Customize site ICFs with site contact details as needed • Perform remote review of EMR/EHR checklists 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 site staff with vendor-related 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 updating in systems • Follow up on missing vendor data such as ECGs, lab samples, and e-diaries • Support 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, or expired documents • Perform other assigned site management tasks and client-requested FSP role profiles • Complete administrative tasks including expense reports and timesheets • Serve as the primary point of contact for sites on legacy studies

🎯 Requirements

• 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 • 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 and strong attention to detail • Ability to handle multiple tasks efficiently and effectively • Flexibility and adaptability • Ability to work independently or in 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 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

• Fully remote work arrangement • Standard Monday–Friday work schedule • Occasional travel to clinics/hospitals may be required • Opportunity to work with a global team supporting pharmaceutical and biotechnology clinical trials • Potential promotional opportunities in the CRA career track

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