Emory University Mgr, Clinical Research in atlanta, Georgia

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:

  • 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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Job Number 24491

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

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled