At a Glance
- Tasks: Assist project teams with regulatory requirements for clinical studies and ensure compliance.
- Company: Join a leading clinical research organisation dedicated to innovation and excellence.
- Benefits: Competitive salary, professional development, and a collaborative work environment.
- Other info: Dynamic team atmosphere with opportunities for international collaboration.
- Why this job: Make a real impact in the healthcare sector while growing your career.
- Qualifications: Degree in health-related field and 3-5 years of regulatory experience required.
The predicted salary is between 69300 - 84700 $ per year.
Please do not apply if you are not fully eligible to work in Australia. CTI doesn't offer any Sponsorship.
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 to 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 bring:
- 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 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience
- Ongoing willingness to learn
- Detail oriented
- Ability to collaborate well in an (international) team environment
- Excellent verbal and written communication skills
- Fluent in oral and written English is a must
- 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
Regulatory Affairs Study Start Up Specialist II in Sydney employer: CTI Clinical Trial and Consulting Services
CTI is an exceptional employer for the Regulatory Affairs Study Start Up Specialist II role, offering a dynamic work culture that prioritises collaboration and continuous learning. Located in Australia, employees benefit from a supportive environment that encourages professional growth through ongoing training and development opportunities, while also enjoying the satisfaction of contributing to impactful clinical studies that enhance healthcare outcomes.
Contact Details:
CTI Clinical Trial and Consulting Services Recruitment Team
We think you need these skills to ace Regulatory Affairs Study Start Up Specialist II in Sydney
Regulatory Compliance
Clinical Study Documentation
IRB/EC Submissions
Quality Control (QC)
Good Clinical Practice (GCP)
International Council on Harmonization (ICH) Guidelines
Communication Skills
