Regulatory Affairs Study Start Up Specialist II

CTI Clinical Trial and Consulting Services; Sydney; On-site; AUD 90,000 - 130,000; Full time

Job summary

CTI Clinical Trial and Consulting Services is seeking a regulatory specialist who can advise project teams on all country-specific regulatory requirements for clinical studies across the globe.

YOU will perform compliance assessments, review site documents, and submit IRB/EC/CA applications as needed, while coordinating with sponsors, sites and CRAs to ensure quality and timely regulatory packages.

Qualifications

• Bachelor's or associate degree in health-related field.
• 3–5 years regulatory experience in pharma, CRO, or site.
• Willingness to learn and adapt to evolving regulations.
• Detail oriented with strong written and spoken English.
• Ability to work effectively in an international team.
• Excellent communication skills in English.

Responsibilities

• Assist/advise on regulatory requirements for clinical studies across countries.
• Perform compliance assessments and notify Project Managers of findings.
• Review study documents per country/site requirements.
• Prepare and submit IRB/EC/CA submissions as applicable.
• QC study documentation and ensure content completeness.
• Coordinate with sites, CPCs, CRAs and PMs for corrections and clarifications.
• Assist audits and inspections readiness.

Skills

Regulatory Knowledge

IRB Submissions

GCP/ICH Knowledge

Documentation QC

Cross-functional Collaboration

English Proficiency

Attention to Detail

Education

Bachelor's Degree in health sciences

Job description

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 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