Clinical Trials Regulatory Specialist III

🕒 Maio 27

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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Emory University

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10.000+ funcionários

📚 Educação

🔬 Ciência

Education • Healthcare • Science

A Emory University, uma das principais universidades de pesquisa localizada em Atlanta, Geórgia, é uma comunidade diversa e engajada eticamente, movida pela investigação, cujos membros trabalham colaborativamente para uma transformação positiva no mundo por meio de liderança corajosa no ensino, pesquisa, bolsa de estudos, cuidados de saúde e ação social.

Descrição

• 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. • Independently prepares IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting. • In concert with IND Sponsors, prepares and reviews IND submissions, communicates with the FDA, and prepares for FDA audits. • 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.

🎯 Requisitos

• 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 practical nurse (LPN) and two years clinical research experience. • Or a Bachelor's degree in a scientific, health related, or business administration 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. • 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 within 2 years of hire (i.e. ACRP, SOCRA, RAC etc.).

🏖️ Benefícios

• Not Applicable