Clinical Research Coordinator 2

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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 excellence of our academic community.

Description

The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. 

KEY RESPONSIBILITIES:

• Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms.
• Provides guidance to less experienced staff.
• Interfaces with research participants, determines eligibility and consents study participants according to protocol.
• Approves orders for supplies and equipment maintenance.
• Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires.
• Supervises collection of study specimens and processing.
• Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed.
• Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors.
• Prepares regulatory submissions.
• With appropriate credentialing and training may perform phlebotomy or diagnostics.
• Performs related approved responsibilities as required.

ADDITIONAL JOB DETAILS:

• Serve as lead coordinator on 3 Cystic Fibrosis clinical trials and enter data into the Cystic Fibrosis clinical database.
• Ability to screen patients from clinic schedules and interface with research participants, determine eligibility and consent study participants according to protocol.
• Ability to coordinate and perform sample collection, processing and shipping.
• Ability to maintain study records and documentation.
• Manages research project databases, and completes source documents/case report forms.
• Ability to work with and be trained in third party electronic data capture (EDC) systems as well as Emory and Children’s Healthcare of Atlanta’s internal tracking and eMR systems.
• Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires.
• Able to attend and present progress in weekly meetings.
• With appropriate credentialing and training, may perform diagnostics and procedures including ECG, vital signs, sweat testing, pulmonary function testing and more. 
• Willing to learn new methods and techniques.
• Able to communicate effectively with clinical staff, research team members and study sponsor representatives.
• Prepares regulatory submissions and is able to complete Institutional Review Board applications and renewals. Also, experience maintaining Investigator Site Files/Regulatory Binders is helpful.
• Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings
• Establishes case packages for study procedures, monitors scheduling of procedures and charges, and coordinates other services as needed.

MINIMUM QUALIFICATIONS: 

• High School Diploma or GED and five years of clinical research experience.
• Or two years of college in a scientific, health related, or business administration program and three years clinical research experience.
• Or a licensed as a practical nurse (LPN) and two years clinical research experience.
• Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience.
• Or a Master's degree, MD or PhD in a scientific, health related or business administration program.

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: 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.

Additional Details

Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with 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 (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 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's advance notice is preferred.