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Regulatory Associate Orlando United States,  

Bio Clinica (company)

Posted on : 26 April 2017

Project Description

Job Description 
The Regulatory Associate is responsible for the processing of regulatory packets/documents, maintenance of regulatory files, and facilitation of IRB submissions per the requirements of ICH-GCP, FDA Regulations, and per protocol.    

Primary Responsibilities:  
  • Prepare regulatory documents for new study submissions to IRB and sponsor 
  • Maintain regulatory files at audit-ready status at all times by ensuring filing are up-to-date upon completion of the processing of new or revised documents 
  • Report protocol deviations and serious adverse events to the IRB according to protocol and IRB requirements 
  • Receive, track, and distribute IND Safety Reports to the Principal Investigator for acknowledgement of review and file. 
  • Submit IND Safety Reports to the study-assigned IRB if submission is not handled by the sponsor 
  • Inform clinical operations of new study approvals including at initiation, amendments, and consent forms upon receipt.  
  • Ensure documents are distributed to the clinical team as appropriate and filed 
  • Communicate and update Sponsor with any revised site information and notify the IRB as required 
  • Liaison with IRBs on a frequent basis to ensure resolution of outstanding submissions requests. 
  • Learn and utilize IRB electronic web portals for the processing of study submissions 
  • Distribute IRB feedback on new study submission to the clinical team and sponsor for resolution of questions or Board requests 
  • Manage the development of new Informed Consent Form drafts with the IRB, as needed, and ensure agreement with ICF language between Compass Clinical Operations teams, IRB, and Sponsor 
  • Obtain Clinical assignments from the Operations teams for the development of new Delegation of Authority Logs and inform teams of missing information or needs for updates to the Logs 
  • Verify protocol training is captured and returned to the regulatory department prior to the assigned staff members completing the Delegation of Authority Logs 
  • Ensure all regulatory books are updated at final monitoring closeout visits 
  • Inform assigned individuals of the need for archiving assistance of closed regulatory books at the defined time frame for long-term storage 
  • Liaison with sponsor monitors during routine and closeout monitoring visits to ensure resolution of outstanding regulatory document requirements are attended to within an appropriate time frame 
  • Schedule monitoring visits, prep books, and assign monitoring space as requested 
  • Provide team assistance on all projects as needed 
  • Assist in the tracking of the status of new study submissions status 
  • Perform ad-hoc projects and/or general office duties as necessary   

Required Skills 
  • Learn and support the organization goals, missions, and values 
  • Good interpersonal, planning/organizational, and communication skills (written and oral) 
  • Ability to handle multiple tasks/projects simultaneously 
  • Attention to detail 
  • Handles confidential information appropriately 
  • Takes initiative and participates as a team player 
  • Knowledgeable with MS Office and Outlook   

Required Experience   
  • Associate s Degree required 
  • Minimum 1 year of research experience required 
  • Certification in Clinical Research strongly preferred (CCRP, CCRC, CIP)   


Orlando Florida United States

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