Regulatory Specialist II (Oncology

Regulatory Specialist II

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

• Bachelor's Degree.
• Two years of experience in academic, government, or industry-based
• 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.

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:

Mon - Fri / 8:30a - 5p FLSA Status:
Exempt

Location:

Hybrid/School of Medicine Campus Department name: SOM Onc Hematologic Malignancies Personnel area:
School of Medicine