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Manager Clinical Research - School of Medicine Anesthesiology

Key Facts

Remote From: 
Full time
English

Other Skills

  • Record Keeping
  • Training And Development
  • Quality Assurance
  • Collaboration
  • Communication
  • Leadership
  • Team Management
  • Detail Oriented
  • Plan Execution
  • Mentorship
  • Problem Solving

Roles & Responsibilities

  • Licensed as a Registered Nurse in the state of Georgia
  • Six years clinical trials research experience including project management or leadership experience
  • Two years of supervisory or managerial experience
  • Previous grant writing experience

Requirements:

  • Provide leadership and oversight of significant clinical research projects, including managing, evaluating, and training research staff (typically eight to fifteen employees)
  • Plan protocols, develop policies, establish standards for the research unit, manage related studies/protocols, and monitor expenses for active protocols
  • Develop and write grant proposals, and assist in grant, contract, and RFP preparation; provide educational information on research protocols and treatment modalities
  • Ensure regulatory compliance across FDA, GCP, ICH and IDE/IND requirements; develop/audit record-keeping procedures and support internal QA/QC processes

Job description

Discover Your Career at Emory University:

Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community.

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.

NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. Emory reserves the right to change remote work status with notice to employee.

Additional Details:

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).

 

Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call 404-727-9877 (Voice) | 404-712-2049 (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.

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