• Senior Clinical Research Associate

    ARTIDIS (Houston, TX)


    About ARTIDIS

     

    ARTIDIS AG is a clinical-stage health-tech start-up founded in Basel, Switzerland, that has developed the first nanomechanical signature for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform, allowing physicians to significantly shorten the current diagnostic process and benefit both the patient and the healthcare system. ARTIDIS enables 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 Senior Clinical Research Associate (SCRA) is an integral part of the Clinical Operations Team which manages the clinical studies. SCRAs work hand in hand with Clinical Quality Development, Clinical Research Associates (CRAs) and Clinical Study Managers (CSMs) to ensure that all clinical studies comply with the approved study protocols and that Good Clinical Practice (e.g. ISO14155:2020, ISO 20916:2019 and/or ICH-GCP E6(R2) as applicable) are being followed. SCRAs also ensure that studies are performed in accordance with applicable regulatory, national and contractual requirements.

     

    SCRAs work on all aspects of clinical studies in ARTIDIS's study sites globally, providing specific oversight on clinical study monitoring activities, clinical study reporting and clinical study processes with emphasis on quality assurance, quality control, compliance and auditing.

     

    Duties and Responsibilities

     

    + Monitors the conduct and progress of the study with focus on all quality related aspects of a study and acts as a main contact point for CRAs and CSMs.

    + Trains and supports CRAs in all their duties as necessary.

    + Provides quality assurance review of all study specific documents.

    + Performs site audits, including source document review, as applicable.

    + Assesses effectiveness of study processes and need for additional training of study teams.

    + Performs periodic internal audits of the documentation of the Trial Master File and of the overall study conduct and compliance with the protocol and applicable regulations.

    + Reviews contracts and budgets and ensures adherence to deliverables and timelines.

    + Acts as a main line of communication between the internal ARTIDIS study team and the internal ARTIDIS Quality team.

    Qualifications

    + Bachelor's degree in a scientific discipline or related field required, or an equivalent combination of education and work experience.

    + 5+ years 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.

    Working Conditions

    The environment is a typical start-up with an intrinsically motivated international team. Our company is an excellent place for rapid advancement and offers a promising opportunity to learn and share know-how in a very 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 is rewarded with challenging tasks, the possibility to take responsibility, a highly driven team, and work serving a significant purpose. The job position comes with a competitive salary and a bonus for outstanding performance.