Assistant CRA

🔥 2 minutes 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 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 to 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 EMR/EHR checklist reviews and support applicable assessments • Verify document collection and RCR submission status; update site EDL and site information • Review patient-facing materials and translations • Support vendor qualification, site-system access, site staff training, IM attendance logistics, vendor trackers and study/site supplies • Support Essential Document collection, review and updating in systems • Follow up on missing vendor data, including ECGs, lab samples and e-diaries • Support ongoing remote review of centralized monitoring tools • Coordinate site payments, system updates, reconciliations and site invoice follow-up • Perform reconciliation tasks involving CRF and query status, deviations, SAEs and safety reports • Drive action for missing, incomplete or expired documents and open document findings • Perform other assigned site management tasks and client-requested FSP role profiles • Complete administrative tasks including expense reports and timesheets • Occasional travel to clinics or 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 • 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, or ability to attain and maintain it • 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 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 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 • Work performed in an office or home office environment • Standard Monday–Friday work schedule • Opportunity to work with a global team • Potential career-track opportunities in Clinical Research Associate roles