Regulatory Specialist II (Oncology)

Johns Hopkins University•Baltimore, MD

3d•Hybrid

About The Position

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.

Requirements

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

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.