Senior Regulatory Affairs study Start Up Specialist

Senior Regulatory Affairs study Start Up Specialist

Job Purpose/

Summary:

Independently 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.

This position will be office based at either our Covington, KY or Raleigh, NC location.

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 each country and site requirements
• Perform / oversee IRB/EC/CA and/ or other Regulatory Bodies 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 according to CTI SOPs, sponsor SOPs and applicable country requirements and /or perform a QC review of all documentation before submitting to the sites, IRB/EC/CA and/or other Regulatory Bodies according to the local requirements
• Adapt Informed Consent Form (ICF) according to IRB/EC requests on country or site level and / or assessing accuracy
• Preparation and/or quality check and filing of site adapted ICF according to local requirements
• Prepare or/and QC Clinical Trial Application forms (e.g. CTA, XML), where applicable
• Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
• Respond to Deficiency Letters from IRB/IEC/CA and/ or other Regulatory Bodies in liaison with sponsor and study PM or assist sites in their response to IRB according to country and site requirements
• Compiling and/or 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 review, reconciliation, close-out, and archiving activities of study or project documentation according to CTI SOPs or sponsor SOPs
• Prepare for Sponsor or Agency audits and inspections
• QC and QA of various study related Regulatory documents and reports
• Oversee translation of regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope
• Attend internal and external study meetings and regulatory status reports for each site and country during study meetings
• Represent the Regulatory Department in capabilities and bid defense presentations
• Train and mentor less experienced Regulatory staff and other CTI functional department staff regarding regulatory work
• Develop relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs
• Sites budgets and Sites contracts management, depending from Countries/Regions

What You ll Bring:

• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
• At least 5 years of relevant pharmaceutical,…