Regulatory Affairs Study Start Up Specialist I

About The Job

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/EC 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/EC/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

Required Education And Experience

• Associate’s or Bachelor’s Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
• A minimum of 1 - 2 years of relevant pharmaceutical, site, or CRO Regulatory experience

Competencies

• Ongoing willingness to learn
• Detail oriented
• Ability to collaborate well in a team environment
• Ability to maintain confidentiality
• Proficient in use of computer and software systems
• Excellent verbal and written communication skills
• Fluent in oral and written English
• Ability to provide superior level of customer service
• Ability to develop, prioritize, organize, and manage multiple tasks
• Decision making and creative problem-solving skills
• Working knowledge and understanding of applicable country regulations, International Council on Harmonization (ICH) / Good Clinical Practice (GCP) regulations and guidelines

Important Note

Please Note

• We will never communicate with you via Microsoft Teams or text message
• We will never ask for your bank account information at any point during the recruitment process.