Regulatory Assistant

Description

Position Summary

The Regulatory Assistant position is responsible for providing support to the Regulatory Administrator through coordinating and documenting internal regulatory processes, such as internal audits, inspections, license renewals, or registrations across multiple studies. This position collaborates with multiple IRBs, sponsoring companies, and co-workers to ensure study documents receive approval and are made available to the site in a timely manner. The Regulatory Assistant will oversee pre-submission to governing agencies and provide foundational information for more complex regulatory work. This position reports to the Regulatory Administrator.  

Position Responsibilities

•  Assist the Regulatory Administrator in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial’s duration for research studies 
• Supports processes and monitors practices to ensure regulatory documentation involving clinical trials complies with the Institutional Review Board (IRB) policies, procedures, and regulations  
• Responsible for study completion processes including reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical data that has been entered on case report forms or in reports and assuring archival of appropriate/required documentation  
• Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process  
• Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies 
• Monitors, detects, and reports adverse events meeting requirements of regulatory bodies in a timely manner  
• Coordinates activities and gathers information from a variety of sources to achieve stated outcomes 
• Completes and maintains regulatory documents for all study personnel, including CVs, licenses, Form FDA 1572, confidentiality agreements, and delegation of duties logs 
• Reviews initial submissions to determine review category and action to be taken  
• Compiles and maintains Paper Investigator Site File (ISF) Binders and eISF
• Completes regulatory applications and other required documentation, prepares protocol specific forms for submission to various review committees, including review boards, the IRB, and sponsors
•  Supports the Regulatory Administrator and Director of Study Management in the day to day activities of regulatory safety management for patients enrolled on research protocols  
• Completes protocol renewal applications, amendment applications, and maintains records of all adverse event reports  
• Attends research team meetings to report on regulatory issues  
• Assists Regulatory Administrator in creating and maintaining protocol specific training documents  
• Communicates with CRA at on-site and/or remote monitoring visits and assists with necessary regulatory tasks 
• Other duties as assigned

Requirements

Skills

• Excellent communication, interpersonal, analytical and problem-solving skills  
• Microsoft Office Suite proficiency 
• Writing and verbal communication skills 
• Knowledge of medical terminology and concepts  
• Proficient typing and data entry skills 
• Ability to work effectively with a team  
• Ability to manage small projects personally and work independently 
• Memory to retain information and know where to research answers 
• Time management skills 
• Organizational skills 
• Detail oriented with the ability to perform at a high level of accuracy 
• Demonstrates strong analytical, problem solving skills  
• Self motivated 
• Must be results oriented, multi-tasking, quick learner 
• Respond to the urgent needs of the team and show a strong track record of meeting deadlines 

Education and Experience

• Associates degree plus two years related work experience or an equivalent combination of relevant post-secondary education and work experience that equals 4 years is required, Bachelor’s degree is preferred  
• Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)  
• Solid understanding of statutes and guidelines relevant to regulatory affairs in clinical research 
• Previous experience in a clinical research setting or related work environment 
• Familiarity with or ability to learn clinical trial management system software  

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel 
• Ability to lift and/or move up to 20 pounds