Inside Higher Ed · 5 days ago
Regulatory Specialist II (Dept. of Electrical & Computer Engineering
Baltimore, MD
Full-time
Hybrid
Entry, Mid Level
$21.17/hr - $37.07/hr
2+ years expInside Higher Ed is seeking a Regulatory Specialist II who will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. This role will serve as a central resource for faculty conducting clinical research and involves collaborating with various teams to ensure compliance and timely submissions.
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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
Coordinate with the protocol compliance team to ensure readiness of regulatory documents prior to study initiation
Collect 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
Other duties as assigned
Qualification
Required
Bachelor's Degree
Two years of experience in academic, government, or industry-based 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
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
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