Social/Clinical Research Specialist

Job description

Position Type:

Department: Globl Hlth and Infect Disease - 427801

Appointment Type:

Vacancy ID: P009395

Position Summary: The primary purpose of this Social/Clinical Research Specialist position will be to prepare submissions to IRB and other regulatory bodies and communicate with staff and outside monitors regarding regulatory issues for clinical trial protocols. This position will work within the regulatory department of the Institute for Global Health and Infectious Diseases for ongoing clinical research studies as a Regulatory Coordinator. Main responsibilities include: -Perform independent and dependable work in preparation and coordination of study submissions to IRB (UNC ethics board) and other appropriate committees following regular deadlines -Communicate with study staff, IRB, sponsors, domestic and international study partners in a courteous/professional manner -Meet with study sponsor representatives -Prepare informed consent forms that follow appropriate regulations and meet sponsor requirements -Address queries and memos from IRB and other committees -Maintain and organize electronic and paper regulatory documents and study files -Perform Quality Assurance/Quality Control of study files -Track and enter regulatory submissions using an electronic database, prepare reports using database -Participate in guideline development as appropriate, streamline processes -Aid in training of study staff on regulatory processes and compliance issues -Communicate potential issues to regulatory supervisor, study team members and investigators -Assist other staff members in completion of work in a team oriented fashion -Complete other regulatory duties as assigned

Application Deadline: 12/10/2018

Education Requirements:

Qualification and Experience: Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

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Job No:
Posted: 12/4/2018
Application Due: 12/10/2018
Work Type: