Regulatory Specialist II (Office of Clinical Trials)

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.

Preferred Qualifications

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