Inside Higher Ed · 2 days ago
Regulatory Specialist II (Office of Clinical Trials)
United States
Full-time
Remote
Entry, Mid Level
$41K/yr - $72K/yr
2+ years expInside Higher Ed is seeking a Regulatory Specialist II to facilitate study startup activities within the Office of Clinical Trials. The role involves ensuring smooth implementation of new trials, monitoring key milestones, and serving as a liaison between study teams and administrative teams.
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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
Qualification
Required
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 high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula
Preferred
One year of experience in a role responsible for study startup activities in interventional clinical trials
Company
Inside Higher Ed
Inside Higher Ed is the online source for news, opinion, and jobs related to higher education.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-01-10Acquired
2006-08-31Series Unknown
Leadership Team
Stephanie Shweiki
Director, Foundation Partnerships
Recent News
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