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    Assistant Director Clinical Research Unit, Pediatrics - Dallas, United States - UT Southwestern

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    Full time
    Description

    SUMMARY

    This position is responsible for the development and implementation of standardized operating procedures for the initiation, execution, and closure of clinical trials and grants and contracts; ensures compliance with regulations; monitors objectives; and provides comprehensive reports. This position must foster a culture that promotes integrity and ethical behavior in all research compliance matters. Strong leadership, communication, and problem-solving skills are also essential for this position.

    EXPERIENCE AND EDUCATION

    REQUIRED

    ·Bachelor's degree required.

    ·Five (5) years' experience.

    ·Three (3) years in supervisory capacity and clinical research experience.

    PREFERRED

    ·Graduate degree preferred.

    JOB DUTIES

    ·Direct and coordinate activities for the Clinical Research Services unit.

    ·Facilitate timely and appropriate communication with Principal Investigators and Research Nurses/Coordinators on all aspects of clinical research administration.

    ·Lead continuous process and operational improvement initiatives to reduce cycle-times, improve overall compliance posture, and remove unnecessary administrative burdens. Ensures the office will provide knowledgeable, friendly, professional, and timely support to clinical research community.

    ·Oversee the clinical trial coverage analyses process and reviews, contract development, and budget negotiation for industry-funded clinical trials and complex non-industry clinical trials.

    ·Oversee the development and maintenance of Velos, the institutional clinical trial management system. Oversee the process to register all clinical trials within institutional clinical trial management system and, as necessary, with federal registry and within institutional clinical trial registries.

    ·Oversee the process to register all clinical trial participants within Velos and, as necessary, with affiliated electronic medical record systems.

    ·Ensure that clinical research income is billed in a timely manner, received timely, and accounted for accurately in institutional financial systems.

    ·Serve as the primary departmental point of contact with affiliate institutions on clinical trial needs, working continually to improve processes and services to ensure limited to no disruption in clinical services.

    ·Establish key operational metrics, publish periodic performance reports to research community, and maintain maximum efficiency and meet performance objectives.

    ·Implement and oversee an ongoing educational and training program for faculty and staff relating to conducting clinical research in partnership with Research Administration.

    ·Establish and maintain policies and procedures related to clinical research billing compliance. Ensures compliance with applicable laws, regulations, policies, and procedures.

    ·Oversee supervisors and/or subordinate managers to include establishing priorities.

    ·**Other Duties: Performs other duties as assigned

    WORKING CONDITIONS

    ·Work is performed primarily in an office setting

    To learn more about the benefits UT Southwestern offers, visit



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