• Senior Clinical Research Associate

    About Gregor Diagnostics

    Gregor Diagnostics Inc. is a Madison, WI based, venture-backed, molecular diagnostics company developing novel molecular diagnostics for improved prostate cancer detection and patient management.

     

    Summary of Major Responsibilities

    The Sr. Clinical Research Associate will be involved in all aspects of clinical trial development and management at Gregor Diagnostics. The Sr. CRA will work directly with sites, physicians, CROs, and other contracted groups to manage all daily and developmental aspects of current and future clinical trials. The Sr. CRA will report to the Director of Clinical and Regulatory at Gregor.

     

    Essential Duties and Responsibilities

    1. Maintain relevant clinical documents, including study protocols, data collection documents, regulatory compliance documents, training documents, standard operating procedures;
    2. Main communication with existing and future sites, PIs, and contractors. Participate in updates to stakeholders and executive management regarding study progress, enrollment updates, and data management updates.
    3. Involved in selection of investigational sites and service providers;
    4. Initiation and successful enrollment at multiple national;
    5. Participate in the adherence review of clinical operation and monitoring plans;
    6. Participate in the sites adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with study site personnel;
    7. Lead ongoing review of data to ensure quality and consistency;
    8. Communicate timely, appropriate project information to project teams, sites and company/sponsor representatives;
    9. Plan and manage site initiation visits, and site onboarding and trainings;
    10. Participate data management of clinical and safety databases;
    11. Assist in budget negotiations and site budget management;
    12. Participate in development of integrated clinical study reports to ensure accuracy, scientific excellence, and congruence of message between studies in a project; and,
    13. Other duties as assigned.

    Qualifications

    Education and industry experience:

    • Bachelor’s degree preferably in Life Sciences or related field plus a minimum of 4 years of clinical trial experience
    • Strong working knowledge in clinical trial management, clinical operations, study enrollment, monitoring and study planning for multiple national sites
    • Experience working with clinical databases, EDC systems, and reporting; Experience in REDCap is preferred
    • Understanding of IRB processes, submissions and requirements
    • Industry experience with in vitro diagnostics (IVD) space preferred; clinical experience in oncology, ideally in diagnostic product development
    • Strong verbal and written communication skills including documentation and regulatory compliance
    • Strong analytical, problem solving and decision-making skills
    • Ability to work in a team environment and adapt to changing plans and circumstances
    • Ability to travel up to 25-40% as required

    Physical Requirements

    • Ability to work for up to 8 hours a day in an office environment.
    • Ability to work up to 6 hours a day in a laboratory environment.
    • Ability to lift and move up to 40 pounds on an occasional basis.

    Job Location

    Gregor Diagnostics is based in Madison, WI. Must be willing to travel up to 25-40% of the time.

     

    Benefits

    Gregor Diagnostics offers a comprehensive and competitive benefits package including:

    • Competitive salary
    • Attractive stock options
    • Health, dental, and vision insurance for employees and family
    • 401k match
    • Flexible paid time off and work schedule

     

    Please submit to: careers@gregordiagnostics.com

     

    Gregor Diagnostics is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law.

     

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