Research Support - Laboratory/Non-Laboratory, Staff/Administrative
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Department: 480502 - HR UTS/UNC Partnership
Location: Chapel Hill, NC
Essential Job Duties:
The Regulatory Assistant gathers, edits, analyzes, and reports data/information for the purposes of communicating with the Institutional Review Board (IRB) and research sponsors. This work is performed in order to comply with federal, state and local laws, regulations and guidelines applicable to the conduct of oncology clinical research.
Support Regulatory Compliance for Assigned groups (Other work responsibilities)
Apply working knowledge of applicable regulations and Clinical Protocol Office (CPO) and IRB procedures to collect, present and maintain essential documents.
Maintain data quality in OnCore, IRBIS and other electronic systems-review data for accuracy and respond to queries
Assist the Clinical team- Data and Study Coordinator and Regulatory Associate as necessary with Sponsor representatives during trial monitoring and/or audit visits.
Maintain IRB Approval of assigned trials, new protocol submissions, amendments and other regulatory actions
Create and maintain essential regulatory documents for assigned trials.
Working knowledge and facility with information technology
Ability to organize, record and present information- to include filing both paper and electronic, take minutes at weekly disease group meetings, physically prepare files for weekly monitor visits (to include transport of files to assigned rooms), walk around health campus to collect signatures for staff and faculty assigned to studies
Lead exchange of information through dialog, instruction and demonstration
Ability to develop working knowledge of regulatory compliance and procedures relating to oncology clinical research
Ability to communicate professionally both verbally and in writing
Knowledge of regulatory policy relating to clinical research and institutional review boards
Required license or certification:
Position Number: 48GR03
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