Regulatory Affairs Study Start Up Specialist; level dependent

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.

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Job Purpose/

Summary:

Manage essential regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB)
Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist and advise study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.

What You’ll Do:

• Assist/Advise project teams on all regulatory requirements for clinical studies
• Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings
• Review and adapt study specific documents according to each country and site requirements
• Perform IRB/EC (CA) submissions on behalf of sponsors and and/or sites as agreed with the Sponsor and in accordance with each country requirements
• Receive and process study documentation from sites, check content and quality as well as completeness
• Interact with site personnel, CPCs, CRAs and PMs, for document corrections, clarification or resolution of any incomplete and/or incorrect documentation found during document content quality review
• Compile Regulatory documentation/timelines according to CTI SOPs, sponsor SOPs and applicable country requirements, perform a QC review of all documentation before submitting to the sites, IRB/EC/CA according to the local requirements
• Assist with and adapt Informed Consent Form (ICF) according to IRB/IEC requests on country or site level
• Assist in preparation, quality check and filing of site adapted ICF according to local requirements
• Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
• Assist in responding to Contingency Letters from IRB/IEC/CA in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements
• Compiling and assessing completeness of the Regulatory-Package for drug release (Regulatory Document Study Start Up Checklist)
• Provide Project teams with accurate periodic status reports in accordance with CTI SOPs and attend internal and external project meetings as needed
• Accurately apply naming conventions, upload and process all correct and complete study documentation in the study start-up module or trackers and study specific TMF system whether electronic or paper
• Perform ongoing maintenance of site documentation throughout the trial
• Perform review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
• Assist with preparation for Sponsor or Agency audits and inspections
• Assist with QC and QA of various study related Regulatory documents and reports
• Oversee translation of…