Regulatory Specialist II (Cardiology)

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. In addition to the duties described above * Coordinate day-to-day clinical trial activities to ensure protocol adherence and efficient study execution. * Support participant screening, enrollment, and scheduling of study visits in collaboration with study teams. * Maintain accurate source documentation and ensure timely, high-quality data entry into study databases. * Assist with safety reporting, including adverse event and protocol deviation documentation, in accordance with regulatory requirements. * Facilitate communication among investigators, study staff, sponsors, CROs, and institutional partners to support ongoing trial operations. * Prepare for and support sponsor monitoring visits, audits, and study close-out activities. Minimum Qualifications * Bachelor's Degree. * Two years of experience in academic, government, or industry-based clinical research. * Familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research. * Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula. Preferred Qualifications * * * Classified Title: Regulatory Specialist II Role/Level/Range: ACRP/03/MB Starting Salary Range: $41,300 - $72,300 Annually ($56,800 targeted: commensurate w/exp.) Employee group: Full Time Schedule: M-F, 8:30 am - 5:00 pm FLSA Status: Exempt Location: Hybird/ School of Medicine Campus Department name: SOM DOM Cardiology Personnel area: School of Medicine