Assistant CRA

🔥 19 hours ago

🤠 Texas – Remote

🤠 Texas – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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 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 • 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 study-specific training and learn study-specific systems • Provide in-house support for pre-study assessments and waivers • Support site ICF customization, EMR/EHR checklist review, document collection, RCR submissions, and site information updates • Review patient-facing materials and translations • Support vendor qualification, system access, site staff training, IM logistics, vendor trackers, and study/site supplies • Support essential document collection, review, and updating • Follow up on missing vendor data, including ECGs, lab samples, and e-diaries • Support centralized monitoring tool review • Coordinate site payment processes, system updates, reconciliations, and invoice follow-up • Perform trial reconciliation tasks involving CRFs, queries, deviations, SAEs, and safety reports • Verify document collection status and drive action for missing, incomplete, or expired documents • Complete administrative tasks such as expense reports and timesheets • Occasional travel to clinics/hospitals may be required

🎯 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 comparable to 0 to 2 years • 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, with proven ability to handle multiple tasks efficiently and effectively • Flexibility and adaptability • Ability to work in a team or independently • 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 • Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered