Assistant CRA – FSP

🕒 May 31

🇩🇪 Germany – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Assistant

🗣️🇩🇪 German Required

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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 site management and monitoring activities on assigned clinical research projects • Review study data from various sources remotely in accordance with regulations, ICH GCPs, and company procedures • Contact study sites to collect documentation, resolve issues, and request outstanding information • Communicate with site staff regarding protocol conduct, enrollment, EDC completion, queries, issues, and site performance • Complete, track, and follow up on subject data in EDC and other systems; raise manual queries when applicable • Review study logs remotely • Conduct and document site management calls and contacts • Participate in investigator meetings • Investigate and follow up on centralized monitoring findings • Evaluate PI oversight, subject safety, study processes, and site capability • Conduct risk-based remote investigations using root cause analysis and problem-solving • Provide refresher training and follow up on regulatory and administrative documents • Review clinical listings, track violations and deviations, and monitor site status, enrollment, CRF status, and SAE follow-up • Provide trial status tracking and progress reports to the study manager • Participate in investigator payment processes when applicable • Liaise with internal staff to collect documents and review EDC and file-review findings • Help maintain audit-ready files and comply with CTMS and eTMF data stewardship • Contribute to company, client, and regulatory audit responses

🎯 Requirements

• Bachelor’s Degree in a life science-related field • Prior clinical research experience of 0–1 year, or relevant clinical environment/health sciences experience with formal medical terminology and anatomy training • Knowledge of clinical monitoring through classwork/training • Basic medical/therapeutic area knowledge and medical terminology • Ability to attain and maintain knowledge of ICH GCPs, applicable regulations, and PPD procedural documents • Ability to successfully complete PPD’s Clinical Foundation Training Program (CFP) • Ability to successfully complete the RSM Onboarding Workshop • Fluency in German and English (minimum C1 level) • Ability to evaluate medical research data • Effective oral and written communication skills with medical personnel • Excellent interpersonal and customer service skills • Good organizational and time management skills • Flexibility and adaptability • Strong attention to detail • Critical thinking, root cause analysis, and problem-solving skills • Ability to coach and mentor site personnel • Good computer skills and 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

🏖️ Benefits

• Flexible working models that support work-life balance • Full-time (40 hours/week) • Clear development pathways (e.g., Senior CRA, Lead CRA, CTM) • Award-winning learning and development programme • Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Collaborative environment • Local and global teamwork opportunities

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