Assistant Clinical Research Associate

🔥 4 minutes ago

🇮🇹 Italy – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Perform remote activities on assigned clinical research projects in liaison with the CRA and study Clinical Lead • Support site preparedness and logistics for the monitoring process • Assist with site management and remote monitoring according to SOPs and regulatory guidelines • Complete study and site management activities according to task matrices • Complete study-specific training and learn study systems • Support pre-study assessments, waivers, site ICF customization, and EMR/EHR checklist review • Verify document collection, RCR submission status, site information, and essential document records • Review patient-facing materials and translations • Support vendor qualification, system access, site staff training, IM attendance, vendor trackers, and study/site supplies • Support site payments, invoice follow-up, system updates, and reconciliations • Perform reconciliation tasks involving CRF and query status, deviations, SAEs, and safety reports • Follow up on missing, incomplete, expired, or open document findings • Perform other assigned site management tasks and client-specific FSP role activities • Complete administrative tasks including expense reports and timesheets

🎯 Requirements

• 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 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, strong attention to detail, and ability to handle multiple tasks efficiently • 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 • Ability to extract information from study documents, electronic study data systems, CTMS, and dashboards • Excellent English language and grammar skills • Occasional travel to clinics/hospitals may be required

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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