Regulatory Affairs Study Start-up

**Regulatory Affairs Study Start Up Specialist**

**(Level Depending on Experience)**

**Job Purpose/Summary**

Manage essential Regulatory documentation (as applicable) for submission to country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA) and/or other Regulatory Bodies for all clinical studies performed globally. Interact with, assist and advise the study teams, site personnel, sponsors, and CTI management to facilitate timely collection, assessment and processing of essential regulatory documentation and to provide ongoing status reports about the documentation. Maintain essential regulatory documentation for multiple studies and perform review, reconciliation, close-out and archiving activities of study or project documentation according to CTI or Sponsor SOPs.

**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
- 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**
- 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
- 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

**Why CTI?**

At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.

For that reason, we treat our team members with the respect they deserve, and our numbers show it:

- 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 have never had a