Regulatory Affairs Study Start Up Specialist (level dependent on experience)

CTI Clinical Trial and Consulting Services; Raleigh (NC); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Vacation packages

Hybrid work from home opportunities

Paid parental leave

Job summary

CTI Clinical Trial and Consulting Services seeks a Regulatory Documentation Specialist to manage essential regulatory documentation, assist study teams, and ensure compliance with country requirements across multiple studies. This role requires coordination with sponsors, sites, and CTI management to provide timely status reports and maintain archival quality.

The ideal candidate will have a degree in allied health and 3–5 years of relevant regulatory experience in pharma/CRO settings, with

Qualifications

• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
• A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience.

Responsibilities

• Assist project teams on regulatory requirements for clinical studies
• Perform compliance assessments per country requirements and report findings
• Review study documents per country/site requirements
• Submit IRB/EC/CA submissions for sponsors/sites per country requirements
• Receive and process study documentation from sites; check content and quality
• Assist with preparation for Sponsor or Agency audits and inspections

Skills

Regulatory experience

Documentation management

IRB submissions

Education

Associate’s or Bachelor’s degree in allied health

Job description

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 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 to each country and site requirements
• Perform IRB/EC (CA) 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/timelines 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 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
• Interact with Sponsors as needed; forward regulatory documentation, including final regulatory submission packages, if requested, to Sponsor in accordance with CTI or Sponsor SOPs
• Assist in responding to Contingency Letters from IRB/IEC/CA 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 ongoing maintenance of site documentation throughout the trial
• 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

What You'll Bring:

• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience
• A minimum of 3 - 5 years of relevant pharmaceutical, site, or CRO Regulatory experience

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

• Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note

In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.