Assistant CRA

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🔥 1 minute ago

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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 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 • 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 waivers • Customize site informed consent forms with site contact details as needed • Perform remote review of EMR/EHR checklists and support assessments • Verify document collection and RCR submission status; update site EDL and verify site information • Review patient-facing materials and translations • Support vendor-related site staff qualification processes • Coordinate system access for relevant site staff • Follow up on site staff training • Coordinate logistics for investigator meeting attendance • Maintain vendor trackers and coordinate 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 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 address missing, incomplete, or expired documents • 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 relevant formal academic/vocational qualification • Previous experience providing knowledge, skills, and abilities to perform the job, comparable to 0–2 years • Combination of appropriate education, training, and/or directly related experience may be considered as an equivalency • Basic medical and therapeutic area knowledge • 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 • Strong attention to detail and ability to handle multiple tasks efficiently • 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 • 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 • Standard Monday–Friday work schedule • Home office environment • Reasonable accommodation for individuals with disabilities • Equal opportunity employment

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