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

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

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)

Jefferson

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