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Regulatory Affairs Study Start Up Specialist
CTI Clinical Trial and Consulting Services. Manage essential regulatory documentation for clinical studies throughout the study lifecycle .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing regulatory documentation for global clinical studies, including compliance assessments, IRB/EC/CA submissions, and quality control of study-specific documents. Proficient in coordinating with various stakeholders and maintaining documentation throughout the trial lifecycle.
Highest-signal resume keywords
Regulatory Documentation ManagementIRB/EC/CA SubmissionsCompliance AssessmentQuality Control of Regulatory DocumentsClinical Study Documentation
ATS Keywords
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Hard Skills
Regulatory ExperienceDocument Quality CheckInformed Consent Form AdaptationRegulatory Package CompilationStudy-Specific Document Review
Soft Skills
CollaborationCommunicationProblem-Solving
Tools & Technologies
Study Start-Up ModulesTrackersTMF Systems
Industry Keywords
Clinical StudiesPharmaceuticalCROInstitutional Review BoardsEthics CommitteesCompetent Authorities
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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