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

CTI; Covington (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

CTI Clinical Trial and Consulting Services in Covington, NC seeks a Regulatory Documentation Specialist to manage essential regulatory documentation for global clinical studies and coordinate submissions with IRBs, ECs, and authorities.

You will review study documents, ensure compliance by country requirements, assist project teams, and maintain TMF and submission packages across sites.

Qualifications

• Associate’s or Bachelor’s degree in allied health field such as nursing, pharmacy, or health science or equivalent relevant experience.
• 3–5 years of regulatory/pharma experience.

Responsibilities

• Assist project teams on regulatory requirements for clinical studies.
• Perform country-specific regulatory compliance assessments and report findings.
• Review study documents for country/site requirements.
• Submit IRB/EC approvals on behalf of sponsors/sites per country rules.
• Compile regulatory documentation and conduct QA checks before submissions.

Skills

Regulatory experience

Cross-functional collaboration

Documentation management

Education

Degree in allied health

Job description

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

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

Why CTI?

• Advance Your Career – We invest in your professional growth. Through a structured mentoring program, leadership development courses, and access to ongoing education and training opportunities, including tuition reimbursement, you’ll have the tools to achieve your goals. Our dedicated training department supports your successful career at CTI.


• Be Part of an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with generous health benefits, vacation packages, hybrid work opportunities, and paid parental leave. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.


• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Equal Opportunity Employer/Veterans/Disabled