Clinical Research Associate

About ARTIDIS
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. The ARTIDIS 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. ARTIDIS intends to enable professionals to design personalized cancer treatment plans tailored to individual patients' needs and desired outcomes.

Job Purpose
ARTIDIS, is a medical device start-up company that conducts clinical studies to validate and develop new cases for its medical products. Given that ARTIDIS’s medical devices are unique, the clinical studies are designed and supervised directly by ARTIDIS. The Clinical Research Associate (CRA) is an integral part of the Clinical Operations Team which manages the clinical studies.

CRAs work on all aspects of study processes in ARTIDIS’s 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

• 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.
• 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).
• 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.
• 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.
• 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.
• Provide training and ongoing support to investigators and site staff on study procedures, protocols, and regulatory requirements.

Qualifications

• Education and Experience: Bachelor’s degree in a scientific discipline (or equivalent combination of education and experience) with hands-on experience in conducting clinical studies, including single-center and international multi-center studies with medical devices.
• Regulatory and Technical Expertise: Strong knowledge of regulatory guidelines, GCP standards for medical devices, and familiarity with clinical/health systems.
• Personal Attributes and Skills: Self-driven, organized, detail-oriented, and capable of multitasking effectively in a fast-paced environment. Demonstrates accountability, quality-focused work, and problem-solving capabilities with minimal supervision.
• Communication and Collaboration: Excellent oral and written communication skills with the ability to interact professionally at all levels. Strong team-player attitude with a pragmatic and collaborative approach to clinical research.
• Proficient in Croatian and English (both written and spoken).
  

Working conditions
ARTIDIS is a start-up company with an intrinsically motivated international team. Our company offers an excellent environment for fostering professional development while ensuring a promising opportunity to learn and share knowledge in an agile environment. The position requires the employee to go the extra mile when needed. We are looking for a team player who appreciates direct communication. The effort will be rewarded with challenging tasks, the possibility of taking responsibility, a highly driven team, and working while serving a significant purpose. The job position comes with a competitive salary and bonuses for outstanding performance. The job involves 20% travel.