Perspective
Healthcare
ResearchRegulatorySpecialistSenior
“Research Regulatory Specialist Senior at Perspective. Skills: Regulatory Management, Data Management, Quality Assurance. Provide support for implementation of clinical trials. Perform start-up activities for regulatory documents”
What You'll Achieve.
Implement clinical trials with minimal protocol deviations
Industry & Context.
Correcting errors; Problem solving
What They're Looking For.
Must Have
5 years of experience in clinical research, Associate's Degree, Basic knowledge of computer operations, Demonstrated computer skills in a variety of software environments, Ability to communicate quickly and effectively with the Institutional Review Board
Nice to Have
Previous experience as a regulatory coordinator for industry or non-industry clinical trials, Bachelor's Degree
What You'll Do.
Provide support for implementation of clinical trials
Perform start-up activities for regulatory documents
Ensure submission of documents to sponsors
Ensure submission of documents to IRB
Ensure submission of documents to CRO
Serve as liaison between sponsors and internal departments
Implement clinical trials with minimal protocol deviations
Assist and guide new team members
Manage study regulatory documents
Complete regulatory documents for submission
Complete documents for IRB submission
Meet with leader to discuss new studies
Meet with leader to update current studies
Assist with site visits
Prepare monthly IRB summaries
Prepare weekly summary of tasks reports
Prepare weekly regulatory status reports
Manage and update nursing licenses
Manage and update medical licenses
Assist with completion of data reporting
Submit monthly study financial reports
Participate in internal quality assurance activities
Review clinical research data
Correct errors in data
Coordinate audits for assigned protocols
Assist clinical team in development of training tools
How You'll Work.
Team & Collaboration
Internal departments/staff; Various sponsors; IRB; Contract research organizations; Clinical team
Communication Scope
Communicate quickly and effectively
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