Clinical Trials Regulatory Specialist III

Role Overview

• 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