Senior Regulatory Research Coordinator

Role Overview

• Serves as the primary regulatory contact for assigned protocols.
• Maintains the electronic regulatory binders / files and ensures appropriate version control is in place.
• Coordinates submissions to ancillary committees such as Radiation Safety and Institutional Biosafety.
• Communicates with the IRB and sponsor on behalf of the study team regarding regulatory management.
• Collaborates with the study team and sponsors to finalize documents based on PRMC and/or IRB recommendations.
• Prepares and submits study amendments and continuing review applications for PRMC and IRB review.
• Prepares regulatory files for auditing and monitoring visits.
• Communicating to study teams the importance of adhering to CTO Regulatory processes

Requirements

• HS diploma with 6 years clinical research experience and SOCRA Certification, or
• Bachelor’s degree in a scientific or healthcare-related field with at least 2 years clinical research experience, or
• Master’s degree in a scientific or healthcare-related field with 1 year clinical research experience
• Strong written and oral communication skills
• Attention to detail
• Customer service orientation
• Proven ability to perform work accurately and efficiently
• Experience working with grant funded and Investigator-Initiated clinical trials
• Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials
• Familiarity with terminology and processes associated with the conduct of clinical research
• Experience with clinical trial management systems, such as OnCore and ClinicalTrials.gov
• Demonstrated ability to work independently and with a team
• Demonstrated proficiency with Microsoft Office, including Outlook, Teams, OneNote, Word, and Excel

Benefits

• medical (including prescription) insurance
• supplemental insurance
• dental
• vision
• life and AD&D insurance
• short
• and long-term disability
• flexible spending accounts
• retirement plans
• tuition assistance
• access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service
• access to medical (including prescription) insurance for all colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps)