Regulatory Affairs Study Start Up Specialist II

Australia·Sydneymid

OtherRegulatory Affairs

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Quick Summary

Key Responsibilities

Assist/Advise project teams on all regulatory

Technical Tools

OtherRegulatory Affairs

Responsibilities

~2 min read

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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 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 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

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

- We support career progression – We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward
- We value education and training – We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department
- We value our people - We guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time and a hybrid work from home schedule
- Our culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry
- We think globally and act locally – With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
- We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs
- Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market