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 diversity and excellence of our academic community.

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 required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee.

The COVID-19 vaccine or an approved exemption is currently only required for individuals working in a clinical setting. For more information on the University or Hospital policies, including exemptions, please see our website.

Emory University is dedicated to providing equal opportunities and equal access to all individuals regardless of race, color, religion, ethnic or national origin, gender, genetic information, age, disability, sexual orientation, gender identity, gender expression, and veteran's status. Emory University does not discriminate in admissions, educational programs, or employment on the basis of any factor stated above or prohibited under applicable law. Students, faculty, and staff are assured of participation in University programs and in the use of facilities without such discrimination. Emory University complies with Executive Order 11246, as amended, 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. Emory University is committed to achieving a diverse workforce through application of its affirmative action, equal opportunity and nondiscrimination policy in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Inquiries regarding this policy should be directed to the Emory University Department of Equity and Inclusion, 201 Dowman Drive, Administration Building, Atlanta, GA 30322.

Emory University is committed to providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at 404-727-9877 (V) | 404-712-2049 (TDD). Please note that one week advance notice is preferred.