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.
This is a Regular part-time (hourly) position for up to 10% FTE. Anticipate 2-5 hours per week, variable depending on FDA regulatory requirements for an ongoing IND-investigator/sponsor multi-center phase 3 clinical trial.
Expertise in FDA regulatory activities a pre-requisite, with working knowledge of ongoing Sickle Cell Disease Treatment with Arginine therapy (STArT) trial. Will manage research project regulatory documentation, submit IRB documents as needed, review CRFs, maintain study site 1572s, 1571, review DOAs, interact with FDA as needed and Data Coordinating Center (university of Utah), participate in virtual study steering committee meetings and working clinical coordinating center - DCC scheduled meetings (up to 1-2 hour meetings weekly), ensure compliance with research protocols, review case reports and audits for accuracy with source documents, attend monitoring meetings with sponsors as needed, prepare regulatory submissions, preforms related approved responsibilities. Hours flexible except pre-scheduled team meetings/steering committee meetings.
This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of CLINICAL RESEARCHER.
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 remote work status with notice to employee.
To ensure the safety of our campus community, the COVID-19 vaccine is required. For more information on the University and Hospital policies and potential 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. 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.