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

Under general supervision, the Clinical Research Coordinator II is responsible for managing complex, FDA-regulated clinical trials, with primary responsibilities that include participant recruitment and screening, informed consent, visit scheduling, source documentation, data collection, and regulatory compliance. The role also involves supporting laboratory activities such as specimen processing, maintaining equipment and supplies, and managing research inventories, including ordering. Additional duties include preparing for monitoring visits and audits, coordinating with internal teams and external sponsors, and ensuring adherence to Good Clinical Practice (GCP), FDA, and DEA regulations. With appropriate training and credentialing, limited clinical procedures may be performed.

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.

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.

PREFERRED QUALIFICATIONS:

• Prior experience working on FDA-regulated clinical trials and/or a demonstrated interest in psychiatric research is preferred.
• This position supports research conducted within the Emory Healthcare Veterans Program (EHVP) and includes investigational studies involving MDMA- and psilocybin-assisted therapy for PTSD.
• Projects may incorporate neuroimaging, psychophysiological assessments, and other translational research methods aimed at advancing PTSD treatment and understanding resilience and risk factors.
• Bachelor's degree in a scientific, health-related, or business administration program and one (1) year of clinical research experience.

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 required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this 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.