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