Regulatory Affairs Study Start Up Specialist

🔥 1 minute ago

🐎 Kentucky, North Carolina – Remote

🐎 Kentucky – Remote 🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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CTI Clinical Trial and Consulting Services

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1999

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

CTI Clinical Trial and Consulting Services is a full-service contract research organization (CRO) that provides clinical trial execution, regulatory strategy, lab and bioanalytical services, real-world evidence generation, and research center management to biotech and pharmaceutical sponsors. With expertise across Phase I–IV studies and complex therapeutic areas (including rare diseases, cell and gene therapy, oncology, neurology, and transplantation), CTI supports study design, site management, patient recruitment, monitoring, safety/pharmacovigilance, biometrics, and quality assurance. Headquartered in Covington, KY, the company emphasizes integrated, patient-centric approaches and global regulatory guidance to accelerate development and bring therapies to patients.

📋 Description

• Manage essential regulatory documentation for clinical studies throughout the study lifecycle • Assist and advise project teams on regulatory requirements • Perform compliance assessments and notify Project Managers of findings • Review and adapt study-specific documents for country and site requirements • Perform IRB/EC/CA submissions on behalf of sponsors and/or sites • Receive, process, and quality-check study documentation from sites • Coordinate with site personnel, CPCs, CRAs, PMs, sponsors, and CTI management to resolve documentation issues • Compile regulatory documentation and timelines and perform QC reviews before submission • Assist with and adapt site-specific Informed Consent Forms • Forward regulatory documentation and final submission packages to sponsors as requested • Assist with responses to contingency letters from IRB/IEC/CA • Compile and assess regulatory packages for drug release • Provide periodic regulatory status reports and attend internal and external project meetings • Apply naming conventions and upload/process documentation in study-startup modules, trackers, and TMF systems • Maintain site documentation throughout the trial • Perform review, reconciliation, close-out, and archiving activities • Assist with sponsor or agency audits and inspections • Assist with QC and QA of regulatory documents and reports • Oversee translation of regulatory documents when needed • Attend study meetings and provide regulatory status reports for each site and country

🎯 Requirements

• 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 • Ability to manage essential regulatory documentation for global clinical studies • Knowledge of country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA), and other Regulatory Bodies • Ability to perform compliance assessments according to country requirements • Ability to review and adapt study-specific documents to country and site requirements • Ability to perform IRB/EC/CA submissions according to country requirements • Ability to compile, assess, quality check, file, maintain, reconcile, close out, and archive regulatory and study documentation • Ability to assist with Informed Consent Form adaptation according to IRB/IEC requests • Ability to prepare status reports and regulatory submission timelines • Ability to use study start-up modules, trackers, and electronic or paper TMF systems • Ability to assist with sponsor or agency audits and inspections • Ability to oversee translation of regulatory documents when needed

🏖️ Benefits

• Structured mentoring program • Leadership development courses • Ongoing education and training opportunities • Tuition reimbursement • Generous health benefits • Vacation packages • Hybrid work opportunities • Paid parental leave • CTI Cares community and global giving opportunities