- The Regulatory Specialist II is an intermediate level position supporting regulatory affairs in clinical trial research.
- Incumbents are responsible for coordinating and supporting regulatory affairs activities for non-interventional and interventional trials for IRB submission.
- Incumbents may support an extensive and complex portfolio of trials.
- Duties include:
- Supports clinical research team (physicians, 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.
- Documents any exceptions to compliance standards.
- Manages new submissions, amendments, safety reports, and continuing review activities.
- Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports, deviations, and review of safety reports.
- 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.
- Serves as primary contact for each assigned trial, maintains records and corresponds with all parties involved (institutional, federal, pharmaceutical).
- Provides direction and feedback to research team to ensure awareness of business practices and quality standards.
- 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.
- Attends research team meetings to report on regulatory issues.
- Responsible for administrative duties corresponding to budgets and contracts.
- Performs related responsibilities as required.
- Bachelor's degree and two years of experience in a research environment, or an equivalent combination of experience, education and training.
- Knowledge of IRB processes, federal research regulations and a basic understanding of funding programs and clinical research practices.
- Must obtain all required training courses within one month of hiring date.
- Must possess an applicable research certification.
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Clinical Trials Regulatory Specialist II - Decatur, United States - Emory University
Description
Discover Your Career at Emory University:
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.
Description:JOB DESCRIPTION:
MINIMUM QUALIFICATIONS:
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
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 V) | TDD). Please note that one week advance notice is preferred.
