CRA, Study Start-up and Maintenance
6 dni temu
- site and project coordination: act as the main point of contact for clinical sites throughout the study lifecycle, providing support for site initiation, compliance, and regulatory documentation,
- documentation & tracking: maintain and update project documentation, tracking activities, site status, and action items according to SOPs,
- site activation & regulatory submission: assist in preparing essential regulatory documents for site activation, submitting them to appropriate regulatory bodies (e.g., FDA, EU CTIS) in compliance with ICH-GCP and local regulations,
- regulatory maintenance: oversee regulatory updates, including protocol amendments, safety reports, and IRB/IEC submissions, ensuring all documentation is current and compliant,
- training & compliance: complete required training and keep up-to-date with ICH-GCP guidelines and relevant local regulations,
- budget and contract: oversight and liaison between site and sponsor with budget and contracts.
- proven experience in study start-up processes in clinical researche,
- experience with local CTIS regulatory submissions,
- working knowledge of ICH-GCP and local regulatory guidelines,
- strong communication, organizational, and multitasking skills.
- employment based on a contract of employment,
- friendly work environment – we hold a Friendly Workplace certification,
- comprehensive non-wage benefits package,
- remote work arrangement.
- private medical care
- sharing the costs of foreign language classes
- remote work opportunities
- flexible working time
- corporate products and services at discounted prices
- integration events
- Analiza CV
- Spotkanie Rekrutera/Hiring Managera z wybranymi kandydatami
- Zadanie rekrutacyjne (w zależności od stanowiska)
- Podjęcie decyzji
Grupa NEUCA jest kompleksowym partnerem na rynku ochrony zdrowia, tworząc nową jakość usług we wszystkich jego obszarach.
Działa na rynku od ponad 30 lat, łącząc potrzeby farmaceutów, pacjentów i producentów.
Grupa NEUCA wspiera niezależne apteki, jest liderem w dostarczaniu farmaceutyków, rozwijając jednocześnie sieć centrów medycznych Świat Zdrowia oraz ośrodki Badań Klinicznych.
Wszystkie informacje o przetwarzaniu danych osobowych w tej rekrutacji znajdziesz w formularzu aplikacyjnym, po kliknięciu w przycisk "Aplikuj Teraz".-
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