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Clinical Research Associate Specialist
vor 1 Woche
ARTIDIS AG is a clinical-stage health-tech start-up company founded in Basel, Switzerland that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. Our nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, intended to allow physicians to significantly shorten the current diagnostic process and benefit both the patient and the healthcare system.
The Job Purpose is to conduct clinical studies to validate and develop new cases for our medical products. Given that our medical devices are unique, the clinical studies are designed and supervised directly by ARTIDIS. The Clinical Research Associate (CRA) plays an integral part in the Clinical Operations Team, which manages the clinical studies.
We require CRAs to work on all aspects of study processes in our study sites globally, including site selection, initiation, monitoring, and close-out visits. They ensure that the study complies with the approved study protocol and Good Clinical Practice (e.g., ISO14155:2020, ISO 20916:2019 and/or ICH-GCP E6(R2) as applicable) are followed. They also ensure that the study is performed in accordance with applicable regulatory, national and contractual requirements.
Duties and Responsibilities
- Clinical Study Oversight: Participate in the design, planning, and implementation of clinical studies, including tracking key activities such as site activation, patient recruitment, and data collection to ensure alignment with study objectives.
- Regulatory and Documentation Compliance: Review and update study protocols and other documents in adherence to regulatory, GCP, and QMS requirements. Prepare and manage submissions to Ethics Committees (ECs), Institutional Review Boards (IRBs), and Regulatory Authorities (RAs).
- Site Management: Conduct site selection, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory standards. Act as the primary liaison between study sites, vendors, and the internal study team.
- Data and Safety Management: Support data management activities, including data entry, query resolution, and data review. Oversee safety reporting to ensure compliance with the study protocol and regulatory requirements.
- Trial Master File and Audits: Maintain accurate and complete documentation of the Trial Master File globally and conduct site audits, including source document review, to ensure readiness for regulatory inspections.
- Investigator and Site Training: Provide training and ongoing support to investigators and site staff on study procedures, protocols, and regulatory requirements.
