Senior Regulatory Affairs study Start Up Specialist - Raleigh

Only for registered members Raleigh, United States

1 week ago

Job summary

Independently manage essential regulatory documentation 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. 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 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 in accordance with each country requirements Receive process study documentation from sites check content quality as well as completeness Interact with site personnel CPCs CRAs PMs document corrections clarification resolution incomplete incorrect documentation found during document content review Compile regulatory documentation CTI SOPs sponsor SOPs applicable country requirements QC review all documentation before submitting sites IRB/EC/CA other Regulatory Bodies local requirements Adapt Informed Consent Form ICF according to IRB requests on country level assessing accuracy Preparation filing site adapted ICF local requirement Prepare QC Clinical Trial Application forms CTA XML where applicable Interact Sponsors needed forward regulatory documenting include final submission packages requested Sponsor in accordance CTI sponsor SOP Respond Deficiency Letters IRB IECEC CA liaison sponsor study PM assist assist respond accuracy periodic status reports internal external meetings upload process correct complete study start-up module trackers TMF system perform activities close-out archiving activities in accordance CTI SOP sponsor SOP Prepare Sponsor Agency audits inspections QC QA various related documents reports Oversee translation regulatory documents if needed scope Attend meet attend representation capabilities bid defense train mentor staff given work monitor updates current processes.

Job description

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