Emory

  • Mgr, Clinical Research

    Job Number
    19076
    Job Type
    Regular Full-Time
    Division
    School Of Medicine
    Department
    SOM: Orthopaedics: Admin
    This position may involve the following Health and Safety issues:
    Not Applicable
    Job Category
    Business Operations
  • Description

    JOB DESCRIPTION:

    • Provides leadership and oversight of significant clinical research project(s) with an emphasis on managing, evaluating and training research staff.
    • Recruits, orients, and typically manages a research and administrative staff of eight to fifteen employees.
    • Plans protocol, develops policies and establishes standards for the research unit.
    • Develops and writes proposals for grants to conduct research.
    • Manages research studies and related protocols.
    • Acts as a resource person for the medical staff and community outreach. Develops and provides educational information and expertise in research protocol and research driven treatment modalities.
    • Collaborates with others to develop and oversee effective internal quality assurance and control procedures.
    • Plans and develops budgets for new protocols. Regularly monitors expenses and receipts for active protocols.
    • Develops plans to ensure clinical research generates sufficient income to cover operating expenses.
    • Demonstrates a knowledge of and competency in all regulatory requirements (FDA, GCP, ICH and HIC.).
    • Submits applications and maintains Investigational New Drug (INDs) and Investigational Device Exemptions (IDEs) with the FDA.
    • Responsible for regulatory compliance at every level.
    • Develops and audits appropriate record-keeping procedures.
    • Develops and prepares operational and statistical reports for management and regulatory agencies.
    • Provides information for grant and contract applications and assists in the preparation of grants, contracts, and Requests for Proposal (RFPs).
    • Performs related responsibilities as required.


    MINIMUM QUALIFICATIONS:

    • MUST BE a Licensed as a Registered Nurse in the state of Georgia.
    • Six years clinical trials research experience which includes previous project management or leadership experience.
    • Two years of supervisory or managerial experience.
    • Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.
    • Previous grant writing experience.
    • Knowledgeable and proficient in the use of various computer applications/systems.
    • May be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents.

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