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

• Participates in the design, planning, implementation, and overall direction of clinical research projects
• Participate in the design, planning, and implementation of clinical studies.
• Track key study activities (e.g., country start-up, site activation, patient recruitment, patient status, data collection, data review, etc.).
• Develop or assist in the development of the study protocol and/or other study documents as well as updating these documents in accordance with regulatory and GCP requirements.
• Prepare or assist in the preparation of applications and continued correspondence with Ethics Committees (ECs)/Institutional Review Boards (IRBs) and Competent Authorities (CAs)/Regulatory Authorities (RAs), as applicable, including local authorities when required.
• Perform feasibility assessments to identify potential study sites and other involved parties, e.g., laboratories, as applicable.
• Perform site selection, initiation, monitoring, and close-out visits to verify compliance with study protocol requirements, QMS, and regulatory requirements, as well as Good Clinical Practice of ARTIDIS study sites.
• Maintain up-to-date documentation of the Trial Master File for all study sites globally, including periodic reviews.
• Monitor study conduct and progress and contribute to the identification and resolution of issues that may impact the delivery of the study or the necessary quality, timeline, or budget objectives.
• Coordinate with vendors used in the study, e.g., laboratories and pharmacies, and ensure that the study protocol is followed by verifying that all relevant documentation (i.e., accreditation documents, normal ranges, etc.) are kept up-to-date and filed accordingly.
• Provide oversite and act as a main contact for study sites and/or other vendors.
• Act as a main line of communication between the internal ARTIDIS study team and the study site staff involved in the study.
• Provide input and revise data management deliverables (e.g., Data Validation Specification, Data Management Plan).
• Monitor study subject enrollment and study progress at study sites.
• Contribute to the planning and conduct of internal and external meetings (e.g., Investigator/Monitor meeting).
• Ensure accountability and the supply of study material as applicable.
• Report and confirm that safety documentation and reporting are managed according to the protocol, applicable processes of the QMS and regulatory requirements, as well as local requirements.
• Responsible for or assisting with data management activities such as data entry in the database, data query resolution, and data clean-up activities.
• Verify that sponsor and site file(s) are up to date and complete prior to archiving.
• Perform site audits, including source document review, as applicable.
• Comfortable with measurement procedures of the ARTIDIS Medical Device.

Qualifications

• Strong interpersonal, organizational, and multi-tasking skills; attention to detail
• Bachelor’s degree in a scientific discipline or related field required, or an equivalent combination of education and work experience.
• Hands-on experience in conducting clinical studies, including both single-center and international multi-center studies.
• Thorough knowledge of regulatory guidelines and regulations and applicable GCP standards for medical devices.
• Knowledge of clinical/health systems and practices appropriate to the country/region where study-related activities are conducted.
• Skilled in the use of statistical, technical, and database computer applications.
• Self-driven and able to work effectively in a fast-paced environment with minimal supervision.
• Collaborative with a team-player attitude, pragmatic approach and creative problem-solving capabilities.
• Ability to thrive with minimal supervision.
• Strong organizational skills and an ability to multitask with a thorough attention to detail.
• Accountable and able to maintain a strong commitment to producing work of quality.
• Ability to communicate and interact competently and professionally at all levels within a broad, complex, clinical research environment.
• Excellent oral and written communication skills in English. Oral and written communication skills in German are a plus.

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.