Assistant CRA

🔥 0 minutes ago

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 provide logistical support to 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 training on 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 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 vendor qualification, system access, site staff training, IM attendance logistics, vendor trackers and study/site supply management • 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 • Support site payment processes, system updates, reconciliations and site invoice follow-up • Perform trial reconciliation tasks involving CRF and query status, deviations, SAEs and safety reports • Verify document collection status and drive action for missing, incomplete or expired documents and open findings • Perform other assigned site management tasks and client-requested FSP role profiles • Complete administrative tasks such as expense reports and timesheets • May perform limited site contact activities during study start-up, site management, recruitment and close-out phases

🎯 Requirements

• Bachelor's degree in a life science discipline or related field, or Registered Nursing certification or equivalent and relevant formal academic/vocational qualification • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 2 years • 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 • 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 and German language and grammar skills

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Home office environment • Occasional travel to clinics/hospitals may be required • Opportunity to work with a global team at the forefront of clinical research innovation • Career progression opportunities into CRA roles (promotional opportunities may involve frequent travel)

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