Regulatory Specialist II (Dept. of Electrical & Computer Engineering

We are seeking a Regulatory Specialist II who will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. This role will serve as a central resource for faculty conducting clinical research.

Specific Duties & Responsibilities

• Collaborate with the Research Nurse and / or Principal Investigator to ensure timely and accurate submissions to the IRB and study sponsors.
• Obtain and prepare all required documents for new IRB submissions, including initial study submissions.
• Oversee the smooth implementation of new clinical trials from study conception through activation.
• Coordinate with the protocol compliance team to ensure readiness of regulatory documents prior to study initiation.
• Collect all required regulatory documents from participating sites when JHU / JHM serves as the coordinating center, ensuring timely collection
• Develop and maintain standard operating procedures (SOPs).
• Support auditing and monitoring activities, including those involving external sites.
• Act as a central resource for faculty conducting clinical research.
• Prepare and manage required regulatory documentation, including financial disclosure forms, delegation logs, FDA Form 1572, and others.
• Maintain an organized regulatory binder (electronic or physical), initiating with required documents and structured for ongoing updates.
• Ensure prompt reporting of serious adverse events (SAEs) and protocol deviations in accordance with applicable regulations.
• Track protocol submissions through the IRB and relevant subcommittees, identifying bottlenecks and implementing process improvements.
• Attend and contribute to study start-up meetings.
• Participate in routine and as-needed monitoring visits.
• Assist in preparation for and follow-up of regulatory inspections and audits.
• Other duties as assigned.

Minimum Qualifications

Classified Title : Regulatory Specialist II

Role / Level / Range : ACRP / 03 / MB

Starting Salary Range : $21.17 - $37.07 HRLY (Commensurate w / exp.)

Employee group : Casual / On Call

Schedule : M-F

FLSA Status : Exempt

Location : Hybrid / Homewood Campus

Department name : Dept of Electrical and Computer Engrg

Personnel area : Whiting School of Engineering