Research Compliance Analyst at The Ohio State University in Columbus, Ohio

Job Description:

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Job Title:Research Compliance AnalystDepartment:CCC | Administrative Office

The Research Compliance Analyst ensures that research protocols from the OSUCCC Clinical Trials Office (CTO) are submitted for review by the appropriate agency.

Responsibilities

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  Collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included

  
  


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  Conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review Ensures timely submission of protocol documents for review by appropriate agency communicates with all CTO research projects sponsors (academic, federal, industry) to ensure compliance

  
  


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  Interfaces with various internal and external entities to coordinate and effectively compile all appropriate data relevant to the conduct of a CTO trial

  
  


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  Develops IRB submission packets for protocols, including writing of abstract, submission of standard forms and drafting of informed consent forms

  
  


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  Provides and maintains tracking system to assess progress of a protocol's review

  
  


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  Maintains regulatory essential files on submitted and approved studies

  
  


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  Reviews all protocol revisions and amendments

  
  


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  Amends consent forms if needed and follows established guidelines to determine if amendments requires IRB review

  
  


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  Distributes all amendments and IRB approved informed consent forms to relevant university protocol holders

  
  


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  Acts as main point of contact for the dissemination of all approved study material and works collaboratively with various internal and external departments to ensure relevant updates are communicated effectively and timely

  
  


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  Serves as principal contact from CTO to regulatory agencies including FDA and IRBs

  
  


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  Continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements

  
  


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  Provides regulatory updates and guidance to investigators and research staff of new or changed regulations

  
  


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  Participates in audits, site visits and attends meetings

  
  

Minimum Required Qualifications

Bachelor's Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; 1 year experience in research or administrative capacity working on research projects; knowledge of research regulations, guidelines and compliance issues required; experience developing informed consent documents and preparing regulatory documents desired; experience and knowledge of IRB and federal or industry sponsor processes and requirements preferred.

Starting Pay: $27.93 / Hour

Research Administration - Research Compliance - S2

Additional Information:Location:Remote LocationPosition Type:RegularScheduled Hours:40
Shift:First Shift

Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.

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