RASSU Spec II; European lead

Puesto: RASSU Spec II (European lead role)
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 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

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

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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