Clinical Research Associate
il y a 1 semaine
CRA
Junior CRA position:
- Conduct feasibility and site qualification visits,
- Prepare and conduct site initiation visits, monitoring, site closure in accordance with GCP and study procedures,
- Write visit reports and contribute to study progress reports for project team and sponsor,
- Train the principal investigator and the investigational team on the study protocol, documentation, and study procedures,
- Ensure investigator adherence to GCP standards,
- Ensure adequate filing and maintenance of documents in the Investigator Site File,
- Retrieve the essential documents required for the Trial Master File,
- Monitor patient enrollment progress and follow up on site performance and inclusions.
- Oversee materials and products in the sites, including returns of materials,
- Perform source data verification and ensure the accuracy and quality of collected data.
- Support regulatory document reviews as part of EU legal representation activities.
Clinical trial site coordinator position:
- Act as the primary contact between the Sponsor or CRO and the site.
- Track patient enrollment and actively support the site in achieving enrollment goals
- Perform accurate and timely data entry into study specific eCRF and address queries promptly
- Maintain study specific and general tracking of documents at the site level.
- Manage site-specific documentation and maintain regulatory compliance at the site level.
- Assist in scheduling and preparing for monitoring visits, audits, and inspections.
**Requirements**:
- Bachelor’s degree in Life Sciences/Health/Pharmacy
- Mastery of GCP/ISO14155 (valid certification required) and regulations in force
- Operational field experience: At least 1-year experience as CRA or combination of CRA and other clinical research relevant experience
- Excellent organizational and multitasking abilities.
- Strong interpersonal and communication skills to engage with site staff and sponsors effectively.
- Proficiency in data entry and familiarity with eCRF systems.
- Problem-solving mindset and attention to detail.
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