Atlanta, GA, USA
1 day ago
Protocol Regulatory Analyst, Senior- Winship Cancer Institute
Protocol Regulatory Analyst, Senior- Winship Cancer Institute Job Number 142903 Job Type Regular Full-Time Division Exec.V.P. for Health Affairs Department Winship Clinical Trials Job Category Clinical Research Campus Location (For Posting) : Location US-GA-Decatur Location : Name Winship Clairmont Admin Annex Remote Work Classification Primarily On Campus Health and Safety Information Not Applicable 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:

Works directly with faculty and staff to ensure protocol submission quality and accuracy. Develops and manages protocol registration timelines. Provides clinical research team (physician-investigators, clinical research staff, nurses, etc.) protocol management support for initial submissions, tracks and captures protocol statuses throughout their lifecycle, and reports trial activity to multiple oversight authorities (institutional leadership, IRB, NCI, Clinicaltrials.gov). Leads continuous quality control checks to identify missing data or inconsistencies across multiple databases. Builds systems and processes to facilitate protocol data quality control and management. Executes data reporting functionality to provide federal organizations and institutional stakeholders with relevant data associated with Cancer Center Support Grant (CCSG) standards. Researches and analyzes problems and takes a leadership role in resolving. Serves as a project liaison to other teams, departments, the IRB, outside organizations and government agencies. Provides ongoing monitoring and analysis of federal guidelines to ensure compliance. Creates and implements processes to ensure regulations are met; i.e. checklists and workflows with other departmental study teams. Develops and maintains internal work instructions, tools/materials, and documentation for this position. Actively participates in designated committees within the unit and Emory University. Assists in the preparation of tables, graphs, and reports for publication and presentation. Performs related responsibilities as required.

MINIMUM QUALIFICATIONS:

Bachelor's degree and three years of experience in a research environment, or an equivalent combination of experience, education and training. Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices. Must obtain all required training courses within one month of hiring date. Additional Details

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.

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