Regulatory Affairs Study Start Up Specialist

This is a fully remote position, open to applicants in Kentucky, +1 more state.

📋 Description

• Oversee critical regulatory documentation for clinical studies throughout their lifecycle.

• Support and guide project teams regarding regulatory requirements.

• Conduct compliance assessments and inform Project Managers of the results.

• Review and modify study-specific documents to meet country and site requirements.

• Handle IRB/EC/CA submissions on behalf of sponsors and/or sites.

• Receive, process, and conduct quality checks on study documentation from sites.

• Collaborate with site personnel, CPCs, CRAs, PMs, sponsors, and CTI management to address documentation issues.

• Compile regulatory documentation and timelines, and perform quality control reviews prior to submission.

• Assist in adapting site-specific Informed Consent Forms.

• Forward regulatory documentation and final submission packages to sponsors upon request.

• Aid in responding to contingency letters from IRB/IEC/CA.

• Compile and evaluate regulatory packages for drug release.

• Provide regular regulatory status updates and participate in 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 duration of the trial.

• Conduct review, reconciliation, close-out, and archiving activities.

• Assist with audits and inspections conducted by sponsors or agencies.

• Support quality control and assurance of regulatory documents and reports.

• Supervise the translation of regulatory documents when necessary.

• Attend study meetings and deliver regulatory status reports for each site and country.

⛳️ Requirements

• Associate’s or Bachelor’s degree in a related health field such as nursing, pharmacy, or health science, or equivalent relevant experience.

• A minimum of 3–5 years of pertinent pharmaceutical, site, or CRO Regulatory experience.

• Capability to manage essential regulatory documentation for global clinical studies.

• Understanding of country/regional/site Institutional Review Boards (IRB), Ethics Committees (EC), Competent Authorities (CA), and other Regulatory Bodies.

• Proficiency in performing compliance assessments in accordance with country requirements.

• Skill in reviewing and adjusting study-specific documents to align with country and site requirements.

• Ability to execute IRB/EC/CA submissions in compliance with country regulations.

• Competence in compiling, assessing, quality checking, filing, maintaining, reconciling, closing out, and archiving regulatory and study documentation.

• Capability to assist with the adaptation of Informed Consent Forms based on IRB/IEC requests.

• Ability to prepare status reports and timelines for regulatory submissions.

• Proficiency in utilizing study startup modules, trackers, and electronic or paper TMF systems.

• Ability to support audits and inspections from sponsors or agencies.

• Skill in overseeing the translation of regulatory documents when required.

🏝️ 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.