Regulatory Specialist II (Oncology)
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
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