Emory Healthcare/Emory University Clinical Trials Regulatory Specialist in Atlanta, Georgia
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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.
The Clinical Trials Regulatory Specialist supports the clinical research team (physicians, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.
Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.
Manages identified issues and provides feedback to leadership regarding resolution.
Disseminates information and participates in training. Provides direction and feedback to research team to ensure awareness of business practices and quality standards.
Documents any exceptions to compliance standards. Manages new submissions and continuing review activities.
Reviews initial submissions to determine review category and action to be taken.
Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.
Attends research team meetings to report on regulatory issues. Responsible for administrative duties corresponding to budgets and contracts.
Performs related responsibilities as required.
ADDITIONAL JOB DETAILS:
Establish all clinical trial contracts within Emory and other Reliance IRB's.
Ensure that the study team is compliant with all IRB training requirements.
Manage protocol amendments to include staff notifications and documentation of needed training.
Meet with study monitors to review regulatory documents at intervals predetermined by the sponsor.
Weekly meetings with Hope Clinic regulatory staff, ECC leadership group and study team.
Daily planning with lead Regulatory Specialist.
Bachelor's degree and two years of experience in a research environment, or an equivalent combination of experience, education and training.
Knowledge of clinical research practices.
Must complete all required training courses within one month of hiring date.
Business and/or scientific background.
Clinical research exposure to be knowledgeable about research practices, terminology and documentation.
Previous exposure and understanding of regulatory platforms and databases in conjunction with study sponsors.
Able to organize files, communicate with sponsors and staff.
Professional phone skills.
NOTE: This role will be granted the opportunity to work from home temporarily during the COVID-19 pandemic, with intent to return to an Emory University location in the future. Emory reserves the right to change this status with notice to employee
Emory Supports a Diverse and Inclusive Culture
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. Telephone: 404-727-9867 (V) | 404-712-2049 (TDD).
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.
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Job Number 65684
Job Type Regular Full-Time
Division School Of Medicine
Department SOM: Peds: Infectious Disease
This position may involve the following Health and Safety issues: Working with human blood, body fluids, tissues, or other potentially infectious materials.
Job Category Laboratory
Location : Name Emory Campus-Clifton Corridor
Campus Location (For Posting) : Location US-GA-Atlanta
Emory Healthcare/Emory University
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