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Clinical Research Associate

A

ARTIDIS

Clinical Research Associate

Houston, TX
Full Time
Paid
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  • Responsibilities

    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

    • Design, plan, and implement clinical studies.
    • Manage key study activities including site activation, patient recruitment, data collection, and review.
    • Develop and update study protocols in compliance with regulatory requirements.
    • Handle applications and correspondence with Ethics Committees/Institutional Review Boards, Competent Authorities/Regulatory Authorities, and local authorities.
    • Conduct feasibility assessments and site selection visits.
    • Perform monitoring visits to ensure compliance with protocol and regulatory standards.
    • Maintain Trial Master File documentation for global study sites.
    • Monitor study progress and address issues impacting objectives.
    • Coordinate with vendors to ensure protocol adherence.
    • Act as the main contact between study sites/vendors and internal study team.
    • Provide input on data management deliverables.
    • Monitor subject enrollment and progress at study sites.
    • Assist in planning and conducting meetings.
    • Ensure supply of study materials as needed.
    • Manage safety documentation and reporting.
    • Support data management activities.
    • Verify completeness of sponsor and site files before archiving.
    • Conduct site audits, including source document review.
    • Familiarity with ARTIDIS Medical Device measurement procedures.

    Qualifications

    • Bachelor's degree in a scientific discipline or related field, or equivalent combination of education and work experience.
    • Hands-on experience in conducting clinical studies, both single-center and international multi-center.
    • Thorough knowledge of regulatory guidelines, GCP standards for medical devices.
    • Familiarity with local clinical/health systems and practices.
    • Proficient in statistical, technical, and database applications.
    • Self-driven, excels in fast-paced environments with minimal supervision.
    • Collaborative, pragmatic, and adept at creative problem-solving.
    • Strong organizational skills, detail-oriented, and adept at multitasking.
    • Demonstrates accountability and a commitment to quality work.
    • Effective communication within a complex clinical research environment.
    • Excellent English communication skills.

    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.