What You’ll Do
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- 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 Managersof any findings

- Review and adapt study specific documents according each country and site requirements

- Perform IRB/EC (CA) and/or other Regulatory Bodies submissions on behalf of sponsors 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, 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

- 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

- Prepare 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 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

- 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 regulatory documents, if needed, on behalf of Sponsor, as agreed to in scope xhfqzwm

- Attend internal and external study meetings and regulatory status reports for each site and country during study meetings

- Sites budgets and Sites contracts management, depending from Countries/Regions

What You’ll Bring

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- Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience

- A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience

- Expertise in leading regulatory start-up strategy for European clinical trials applications

- Hands on experience in coordinating, preparing and submitting Part I and Part II applications under Regulation 536/2014 and using CTIS

- Regulatory experience in European countries outside the EU (e.G., UK, Switzerland) is a plus

- Fluent in English

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📌 Rassu Spec Ii (European Lead Role) (Madrid)
🏢 Cti Clinical Trial And Consulting Services
📍 Madrid