Regulatory Specialist II (Office of Clinical Trials)

Regulatory Specialist II

Under the supervision of the Accelerated Study Start-Up Program Manager, we are seeking a Regulatory Specialist II who will serve as a central resource for faculty conducting clinical research. The Regulatory Specialist II will be assigned to a dedicated portfolio of clinical divisions and their investigators working to facilitate study startup and maintenance of commercially sponsored clinical trials. Startup activities include coordination of internal partners (study teams, central research administrative teams) and external partners (commercial sponsors, CROs), feasibility surveys, coordination and initiation of contract and budget activities, and initial applications to the IRB and other regulatory agencies. Maintenance activities include regulatory activities over the duration of the study such as creating IRB submissions such as change in research, continuing review, protocol event report, etc., and managing required documents in the electronic regulatory binder ensuring they are accurate and up to date.

Specific Duties and Responsibilities

• Facilitate accelerated study startup activities including feasibility surveys, coordination and initiation of contract and budget activities, initial applications to the IRB and other regulatory agencies, etc.
• Ensure smooth implementation of new trials from conception through study activation.
• Monitor, track, and report critical study start-up milestones e.g., IRB activities, processing and finalization of contracts, drafting of a complete budget, etc.
• Communicate with, and track activities led by, internal and/or external research team members and collaborators.
• Proactively monitor progress and remove barriers to study site activation Serve as liaison between study teams and central research administrative teams.
• Anticipate and mitigate risks to study start up.
• Assess feasibility and operational needs of new studies.
• Attend study startup meetings.
• Complete IRB submissions for new studies, obtaining documents from the sponsor or creating all required documents as needed.
• Track each protocol through the IRB and subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delays in the approval process.
• Collect all required documents prior to study site activation including investigator and personnel medical licenses, CVs, and training documentation.
• Produce and maintain an electronic regulatory binder using Advarra eReg to manage all required documents for the entire duration of the study, ensuring they are accurate and up to date.
• Create IRB submissions such as change in research, continuing review, protocol event report, etc., as needed for the duration of the study.

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.
• 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.

Preferred Qualifications

• One year of experience in a role responsible for study startup activities in interventional clinical trials.