Job Description

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