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    Clinical Research Nurse Manager - Rochester, United States - Casana Corp

    Casana Corp
    Casana Corp Rochester, United States

    3 weeks ago

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    Description


    Clinical Research Nurse Manager (Rochester, NY)We are seeking a dedicated and experienced nurse with experience running clinical studies to join our dynamic team.

    The Clinical Research Nurse Manager is responsible for oversight and execution of the operational aspects of one or more clinical studies conducted at Casana from protocol development through database management.

    As the leader of the clinical studies team, you will ensure timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations and guidelines governing the conduct of clinical trials.

    The right candidate is an experienced nurse with a strong background in conducting clinical studies under FDA regulations and previous experience working in a Clinical Research Organization (CRO) or similar environment where industry sponsored studies are routinely conducted.

    Reporting to the Chief Medical Officer, the Clinical Research Manager will play a pivotal role in managing our clinical trials, ensuring compliance with regulatory standards, and leading the clinical research team towards achieving study objectives.


    What You'll Do:


    Oversee the planning, implementation, and tracking of clinical studies from initiation to completion in accordance with FDA guidelines and Good Clinical Practice (GCP).Providing guidance and support to the clinical studies team to ensure project milestones are met efficiently and effectively and develop team members professionally.

    Collaborate with internal and external stakeholders, including regulatory bodies, sponsors, and site investigators, to ensure smooth operation of clinical studies.

    Develop and maintain study documentation, including protocols, case report forms (CRFs), consent documents, and study manuals.
    Monitor study progress through data analysis, ensuring compliance with protocols and regulatory requirements, and implement corrective actions as necessary.

    Collaborate with the Chief Medical Officer to manage the budget and resources for clinical studies, including vendor contracts and payments.

    Coordinate the submission of study-related documentation to regulatory authorities and Institutional Review Boards (IRBs).Provide clinical and operational expertise during study design and throughout the trial process, ensuring safety for participants while maintaining operational efficiency.

    Ensure accurate data collection, documentation, and reporting of study results.
    Lead efforts in identifying, evaluating, and resolving clinical trial issues or risks.

    Other responsibilities as neededWhat You'll Bring:
    Bachelor's degree in Nursing, Science, or related field. An advanced degree is preferred.
    Valid NY nursing license or out-of-state license with the willingness to obtain a NY license in short order.

    3-5 years of experience in clinical research, with a strong preference for candidates who have worked in a Clinical Research Organization (CRO) and have direct experience running FDA-regulated clinical studies.

    In-depth knowledge of FDA regulations, GCP, and clinical trial processes.
    Demonstrated leadership skills with the ability to manage and motivate a team.
    Excellent organizational, communication, and interpersonal skills.
    Proficiency in clinical trial management software and MS Office.
    Ability to work independently, manage multiple priorities, and adapt to changing priorities.

    About CasanaCasana is innovating healthcare delivery with a smart toilet seat that enables effortless, integrated, and consistent in-home health monitoring.

    The Heart Seat captures key clinical values, including FDA cleared heart rate, blood oxygenation, and future clinical measurements in development such as blood pressure.

    The healthcare system has been searching for this actionable intelligence for decades, and it turns out, we were sitting on a great idea all along.

    CompensationExact compensation may vary based on skills, experience and location. Our compensation consists of base salary and equity as well as a generous benefits package.

    Casana provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

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