Johns Hopkins University logo
Johns Hopkins University

Department name: IT@JH Networking, Telecom and Data Ctr Personnel area: University Administration

Regulatory Specialist II

Location

United States

Posted

10 days ago

Salary

$41.3K - $72.3K / year

Seniority

Mid Level

No structured requirement data.

Job Description

Regulatory Specialist II

Johns Hopkins University

Role Description 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 - Initial applications to the IRB and other regulatory agencies Maintenance activities include: - Regulatory activities over the duration of the study - Creating IRB submissions such as change in research, continuing review, protocol event report, etc. - Managing required documents in the electronic regulatory binder ensuring they are accurate and up to date 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 Requirements - 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 - 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 - 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 Benefits - Starting Salary Range: $41,300 - $72,300 Annually ($60,000 targeted; Commensurate w/exp.) - Employee group: Full Time - Schedule: M-F/37.5 - FLSA Status: Exempt - Location: Remote - Department name: SOM Admin Res Clinical Research Contract - Personnel area: School of Medicine

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