Clinical Trials Regulatory Specialist III

🕒 May 27

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Emory University

WebsiteLinkedInAll Job Openings

10,000+ employees

📚 Education

🔬 Science

Education • Healthcare • Science

Emory University is a prestigious research university located in Atlanta, Georgia. It offers a wide range of undergraduate and graduate programs across various disciplines including arts, sciences, business, law, and medicine. Emory is known for its commitment to teaching, research, and community service, providing students with a comprehensive educational experience while contributing to advancements in knowledge and societal well-being.

📋 Description

• 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.

🎯 Requirements

• 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.).

🏖️ Benefits

• Not Applicable