Emory Healthcare/Emory University Clinical Research Coordinator III - School of Medicine (Cardiology) 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.
We are looking for an advanced level Clinical Research Coordinator III to support recruitment of patients and regulatory duties. The position will spend an estimated 30% of their time on regulatory needs and 70% on recruitment of patients. 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.
Independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects.
Trains and provides guidance to less experienced staff.
Oversees data management for research projects. Interfaces with research participants and resolves issues related to study protocols.
Authorizes purchases for supplies and equipment maintenance.
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.
Monitors IRB submissions and responds to requests and questions.
Interfaces with study sponsors, monitors and reports SAEs; resolves study queries.
Provides leadership in determining, recommending, and implementing improvements to policies/processes.
Assists in developing grant proposals and protocols.
With appropriate credentialing and training may perform phlebotomy, specimens collection or diagnostics.
May perform some supervisory duties.
Performs related approved responsibilities as required.
ADDITIONAL JOB DETAILS:
Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation.
Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process.
In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies..
Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, bio-sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs.
Performs protocol activation and assist investigators with NCI Registration and Credential Repository (RCR) tasks (i.e. new and renewals).
Reviews initial submissions to determine review category and action to be taken.
Compiles and maintains eRegulatory Binders
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.
(1.) High School Diploma or GED and seven years of clinical research experience. OR
(2.) Two years of college in a scientific, health related or business administration program and five years of clinical research experience OR
(3.) Licensed as a Practical Nurse (LPN) and four years of clinical research experience OR
(4.) Bachelor's degree in a scientific, health related or business administration program and three years clinical research experience OR
(5.) Master's degree, MD or PhD in a scientific, health related or business administration program and one year of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.
NOTE: Position tasks are generally required to be performed in-person at an Emory University location. Remote work from home day options may be granted at department discretion. 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 94150
Job Type Regular Full-Time
Division School Of Medicine
Department SOM: Medicine: Cardiology
This position may involve the following Health and Safety issues: Position involves clinical patient contact., Working with human blood, body fluids, tissues, or other potentially infectious materials.
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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