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    Regulatory Compliance Specialist - Augusta, United States - Augusta University

    Augusta University
    Augusta University Augusta, United States

    1 week ago

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    Description
    About Us


    Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state.

    More than 10,500 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences.

    Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today.

    Our mission and values make Augusta University an institution like no other. We are part of the University System of Georgia.

    Location

    Augusta University- Health Sciences Campus: th Street, Augusta, GA 30912

    College/Department Information


    The Clinical Trials Office (CTO) serves as the initial point of contact and centralized coordinating office for all clinical research conducted within the Augusta University Health System.

    Our mission is to facilitate clinical research by providing quality services, solutions, innovative leadership, the promotion of collaboration, and continuous quality improvement.

    Our operation is based upon a comprehensive "One Stop Shop" concept for investigators and sponsors. The Clinical Trials Office provides oversight and management of clinical studies.

    Job Summary


    This incumbent will work with the research team on IRB regulatory submissions to ensure compliance with human subject research, improve efficiency, fiscal soundness and to grow CTO clinical research.

    Responsibilities

    The duties include, but are not limited to:

    Regulatory Responsibilities:

    Obtaining required research education certificates and documentation from clinical staff and principal investigators to ensure IRB protocol submission is submitted in accordance with all federal rules and regulations.

    Work to complete IRB protocol submissions for all new studies, active study amendments and study continuations/renewals from study startup to closeout as needed, register, and update the Oncore task list.

    Assist with review/audit clinical research protocols for compliance with the terms and conditions of the IRB approval and IRB approved sponsor protocol at the time of participant enrollment, sponsor, or grant agreement, governing laws and regulations, Good Clinical Practice (GCP), and AU policies/procedures.

    Assist and collaborate with internal/external customers during regulatory compliance audits to include responding to management inquiries. Actively participate in research regulatory meetings and provide suggestions for appropriate solutions. Attend all study startup, PSIV and SIV meetings as requested.

    Study Startup Activities:
    As requested, assist with the completion of all startup activities. As requested, assist during regulatory and compliance audits as needed (Le, gathering documentation as requested, responding to management inquires).

    Assist in training of staff as related to IRB protocol submission and required documentation Participate in regulatory meetings as related to all funded studies.


    Other:
    Back up for study startup activities. Back up monitor security requests. Perform other related duties as assigned.

    Required Qualifications

    High School Diploma or GED with 5 years of related experience. OR Associate degree and 3 years of related experience.

    Preferred Qualifications

    Certified Research Coordinator (CCRC) or Certified Clinical Research Professional

    Knowledge, Skills, & Abilities


    KNOWLEDGE
    FDA regulations and GCP/ICH guidelines regarding clinical trials. Research study regulatory processes for human subject research. Proficient in Microsoft Office and other computer software/databases.


    SKILLS
    Excellent interpersonal, written, and verbal communication skills. Exceptional organizational skills with attention to detail.


    ABILITIES
    Ability to maintain confidentiality.

    Shift/Salary/Benefits


    Shift:
    Days; Monday - Friday

    Pay Grade: 12

    Salary to be commensurate with qualifications of selected candidate within the established range (generally minimum-midpoint) of the position.


    Recruitment Period:
    Until Filled.

    Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees.


    Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays.


    Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program.

    Consider applying with us today

    Conditions of Employment

    All candidates are required to successfully pass a Background Check review prior to starting with Augusta University.


    The primary work location for this position is within the Augusta University Medical Center or other Augusta University Health System Clinic Space and is subject to the Centers for Medicare & Medicaid Services guidelines.

    The selected candidate will be required to provide proof of COVID vaccination or an approved exemption.

    Your application to this position confirms you are aware of this requirement and agree to provide proof of either COVID vaccination or our organization's approval of a medical or religious exemption.


    All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during the course of their employment and beyond.

    Other Information


    This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees.

    "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success."


    Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited.

    Equal Employment Opportunity


    Augusta University is proud to be an equal opportunity employer, welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.

    How To Apply

    Consider applying with us today


    Search for Job ID:
    Select University Faculty & Staff > External Applicants if you are a candidate from outside the university.

    Select University Faculty & Staff > Internal Applicants if you are a current university employee.

    If you need further assistance, please contact us at


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