Regulatory Analyst 2

University of Miami - Miami, FL

Hiring: Regulatory Analyst 2 Company: University of Miami Location: Miami, FL Job Posted Time: 2026-09-13 12:28:09 Employment Type: Full-time Target Skills & Keywords : HIPAA, Workday About the job Experience: •2 year of relevant experience •Minimum 2 year of relevant experience Required Skills: •Oversee and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, committees, and industry, academic, and cooperative sponsors. •Submits or assists in the submission of applications for institutional clinical trials. •Sends decision correspondence to appropriate parties, requesting information. •Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to raise awareness of research compliance. •Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.). •Ensures compliance of general and study specific regulatory related processes with institutional SOPs, FDA, NIH, and other applicable regulations. •Adheres to University and unit-level policies and procedures and safeguards University assets. •Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation to study closure, including communicating with ancillary committees, study team, business office, and sponsors. Qualifications: •Bachelor's degree in relevant field •Knowledge of relevant federal, state, and local regulations •Knowledge of procedures associated with clinical trials •Skill in completing assignments accurately and with attention to detail. •Demonstrated capacity to communicate effectively in both oral and written form. •Demonstrated capacity to handle difficult and stressful situations with professional composure. •Demonstrated capacity to maintain effective interpersonal relationships. •Demonstrated capacity to understand and follow instructions. •Any appropriate combination of relevant education, experience and/or certifications may be considered. •The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. Compensation: •Competitive benefits and rewards package •The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!