Clinical Trials Regulatory Specialist III | School of Medicine, Pediatrics

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Description

KEY RESPONSIBILITIES :

• The Regulatory Specialist III is an advanced level position supporting regulatory affairs in clinical trials research.
• Employees in this job class support all trial complexities (basic to multiphase) and manage the study activation process.
• Serves as the internal project manager for assigned specific oncology disease group(s) providing the group with timely updates on the status of submissions and regulatory guidance on study development.
• Liaison between the sponsor the investigator Winship Emory IRBs external IRBs and internal departments / staff.
• Incumbents in this job class may also supervise / train Specialist Is and IIs lead project specific task forces and / or serve as project / process improvement leads.
• Duties include :

Independently prepare IRB documents maintain regulatory files and facilitate regulatory oversight of safety reporting.

ADDITIONAL JOB DETAILS :

PREFERRED QUALIFICATIONS :

MINIMUM QUALIFICATIONS :

NOTE : This role will be granted the opportunity to work from home regularly but must be able to commute to Emory University on a flexible weekly schedule based upon business needs. Schedule is based on agreed upon guidelines of department. This role requires residency in the state of GA. 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 Veterans 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 : (V) (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 or call (Voice) (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination.

Required Experience :

IC

Key Skills

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Employment Type : Full-Time

Experience : years

Vacancy : 1