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Emory Healthcare/Emory University Clinical Trials Regulatory Specialist in Decatur, Georgia

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Description

The Hope Clinic of the Emory Vaccine Center is an international Center of Excellence in clinical and translational research in infectious diseases vaccines, treatment, and prevention. The mission of the Hope Clinic is to conduct human research studies and clinical trials for infectious diseases of public health importance. The clinical studies encompass vaccines, treatments, prevention, community-based research, and laboratory-based translational human immunology.

JOB DESCRIPTION:

  • Supports clinical research team (physician-investigators, clinical research staff, nurses, etc.) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.

  • Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.

  • Manages identified issues and provides feedback to leadership regarding resolution.

  • Disseminates information and participates in training.

  • Provides direction and feedback to research team to ensure awareness of business practices and quality standards.

  • Documents any exceptions to compliance standards.

  • Manages new submissions and continuing review activities.

  • Reviews initial submissions to determine review category and action to be taken.

  • 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.

  • Serves as lead contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).

  • Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.

  • Attends research team meetings to report on regulatory issues.

  • Responsible for administrative duties corresponding to budgets and contracts.

  • Reviews regulatory documentation involving clinical trials to ensure compliance with Institutional Review Board (IRB) policies and procedures and regulations and guidelines.

  • Compares reported data with original source documents.

  • Verifies protocol compliance (i.e. eligibility criteria and informed consent)

  • Provides direction and feedback to research team to ensure awareness of quality procedures.

  • Works cooperatively with clinical research staff to address concerns and communicate findings that can lead to improved clinical trial performance and/or compliance.

  • Utilizes appropriate checklists and report templates to record and report quality assurance findings.

  • Researches and analyzes problems and takes a leadership role in resolving.

  • Identifies and manages issues and provides feedback to leadership regarding resolution.

  • Disseminates information and coordinates or conducts training.

  • Reviews documentation of exceptions to compliance standards to assure information is accurate and complete.

  • Participates in meetings and in-service training requirements.

  • Performs related responsibilities as required.

MINIMUM QUALIFICATIONS:

  • Bachelor's degree and two years of experience in a research environment, or an equivalent combination of experience, education and training.

  • Knowledge of clinical research practices.

  • Must complete all required training courses within one month of hiring date.

PREFERRED QUALIFICATIONS:

  • A sound knowledge of ICH and Food and Drug Administration’s Good Clinical Practice regulations.

  • Attention to detail, organization skills, interpersonal skills, and effective oral and written communication skills.

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.

Emory Supports a Diverse and Inclusive Culture

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.

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 55361

Job Type Regular Full-Time

Division School Of Medicine

Department SOM: Medicine: Infectious Dis

This position may involve the following Health and Safety issues: Not Applicable

Job Category Laboratory

Location : Name Hope Clinic

Campus Location (For Posting) : Location US-GA-Decatur

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