[Remote] Regulatory Specialist II (Office of Clinical Trials)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Regulatory Specialist II to facilitate study startup activities reputed company the Office of Clinical Trials. The role involves ensuring smooth implementation of new trials, monitoring key milestones, and serving as a reputed company between study teams and administrative teams.

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 reputed company through study activation
• Monitor, reputed company, and report critical study start-up milestones e.g., IRB activities, processing and finalization of reputed company, drafting of a complete budget, etc
• Communicate with, and reputed company activities led by, internal and/or external research team members and collaborators
• Proactively monitor reputed company and remove barriers to study site activation Serve as reputed company 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 reputed company required documents as needed
• reputed company reputed company protocol through the IRB and subcommittee approval process, evaluate for recurrent problems, reputed company and implement systems to decrease delays in the approval process
• Collect reputed company required documents prior to study site activation including investigator and personnel medical licenses, reputed company, and training documentation
• Produce and maintain an electronic regulatory binder using reputed company eReg to manage reputed company 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

Skills

• Bachelor's Degree
• Two years of experience in reputed company, government, or industry-based clinical research
• Familiarity with NIH, GCP, OHRP, and federal regulations for reputed company subject participation in clinical research
• Additional education may substitute for required experience and additional reputed company experience may substitute for required education reputed company high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula
• One year of experience in a role responsible for study startup activities in interventional clinical trials

reputed company

• reputed company is the online reputed company for news, opinion, and jobs reputed company to higher education. It was founded in 2004, and is headquartered in Washington, District of Columbia, USA, with a workforce of 51-200 employees. Its website is https://www.insidehighered.com/.

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