Emory Healthcare/Emory University Clinical Research Coordinator IV, School of Medicine: Pediatrics 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.
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.
Recruits, orients, and supervises research administration staff or independently manages the most complex research administration activities associated with the conduct of clinical trials.
Manages a large or multiple smaller clinical research projects.
Manages clinical trials related information systems.
Supervises the implementation of and adherence to study protocols.
Monitors expenditures and adherence to study budgets and resolves
Educates research staff on established policies, processes and procedures.
Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials.
Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes.
Plans, identifies, and handles study related equipment and facilities needs. Provides leadership and expertise in identifying and completing research grants, study materials, brochures and correspondence.
Develops and submits grant proposals.
Leads or chairs committees or task forces to address and resolve significant issues.
Performs related approved responsibilities as required.
(1.) High School Diploma or GED and nine years of clinical research experience. OR
(2.) Two years of college in a scientific, health related, or business administration program and seven years clinical research experience OR
(3.) Licensed as a Practical Nurse (LPN) and six years clinical research experience OR
(4.) Bachelor's degree in a scientific, health related or business administration program and five years of clinical research experience OR
(5.) Master's degree, MD or PhD in a scientific, health related, or business administration program and two years of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.
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.
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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 79761
Job Type Regular Part-Time
Division School Of Medicine
Department SOM: Peds: Emergency Medicine
This position may involve the following Health and Safety issues: Not Applicable
Job Category Research & Research Administration
Campus Location (For Posting) : City Atlanta
Location : Name Emory Campus-Clifton Corridor
Emory Healthcare/Emory University
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