Regulatory Specialist II (Oncology) - #Staff

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 MedicineEqual Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.