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    Senior Clinical Research Associate - Ohio, United States - Growing Medical Company via The Walstrom Group, Inc.

    Growing Medical Company via The Walstrom Group, Inc.
    Growing Medical Company via The Walstrom Group, Inc. Ohio, United States

    2 weeks ago

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    Description

    Position/Title: Senior Clinical Research Associate

    Required Background: Cardiovascular clinical research

    Job Overview:

    As a key team member, you will provide support to clinical sites, sponsors, and staff involved in testing products and conducting trials. You will play a vital role in developing and implementing processes and procedures within the company. Additionally, you may lead monitoring activities on specific trials to ensure compliance with regulations, protocols, and company policies.

    Site Management / Compliance:

    • Ensure compliance with protocols, regulations, and guidelines through training and guidance of personnel, on-site evaluations, and corrective actions.
    • Monitor trial data to maintain accuracy, resolve discrepancies, and collect missing information. Stay updated on clinical trial regulations and act as a resource on the subject.
    • Support and mentor new and junior staff members.
    • Ensure timely collection and maintenance of trial documentation, product supply, and enrollment activities.
    • Handle adverse event reports effectively and attend investigational cases as necessary.
    • Develop expertise in trial therapeutic areas and stay informed about the competitive landscape.

    Clinical Operations:

    • Assist in site start-up activities, personnel document collection, and review of informed consents.
    • Train external organizations and ensure adherence to ethical, regulatory, and clinical standards.
    • Contribute to protocol development and participate in cross-functional meetings and projects.
    • Identify and assess investigators, sites, and organizations, and manage vendors effectively.

    Project Management:

    • Drive projects to completion in collaboration with cross-functional teams.

    Skills/Experience:

    Minimum Qualifications: 4+ years in a related role with in-depth knowledge of the functional area or equivalent combination of education and experience.

    Preferred Qualifications: 8+ years in a related role with expert understanding of the functional area or equivalent education and experience.

    Education/Certification:

    Minimum Qualifications: RN, RT, or associate's degree.

    Preferred Qualifications: RN, RT, bachelor's, or advanced degree in a scientific or technical field. Clinical Research Certification (ACRP, SoCRA).

    Physical Demands/Work Environment:

    50-75% regional travel with possible national travel.

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