Regulatory Specialist II (Cardiology)

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.
• Cookordinate with the protocol compliance team to ensure readiness of regulatory documents prior to study initiation.
• Colelct 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.

Additional Duties

• Coordinate day-to-day clinical trial activities to ensure protocol adherence and efficient study execution.
• Maintain accurate source documentation and ensure timely, high-quality data entry into study databases.
• Aid in 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.

Preferred Qualifications

• 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.