Allied Executive Solutions is a consulting firm serving non-profit and social-impact organizations. Its work combines research and development, grant management, and executive support to help mission-driven teams strengthen their operations, pursue sustainable growth, and create lasting benefits for the communities they serve. The company focuses on tailored support designed around each organization’s goals and needs.
Clinical Research Regulatory Specialist (Hybrid, United States)
Manage IRB submissions, essential regulatory files, and audit readiness for clinical research studies. Support compliance, staff training, and participant protection within an allied research organization.
Description
- Manage regulatory documentation and compliance activities for clinical research studies, clinical trials, and human-subjects research.
- Support study start-up through protocol and sponsor-material review, feasibility assessment, checklists, document collection, and readiness activities.
- Prepare, coordinate, submit, and track IRB applications, amendments, continuing reviews, reportable events, and study closures.
- Keep IRB approvals, consent forms, recruitment materials, protocols, and participant-facing documents current and version controlled.
- Create and maintain regulatory binders and electronic regulatory files.
- Ensure essential regulatory files are complete, accurate, and inspection ready.
- Support quality checks, sponsor monitoring visits, IRB audits, FDA inspections, and internal compliance reviews.
- Help address monitor findings, audit observations, corrective actions, protocol deviations, noncompliance, reportable events, and regulatory follow-up.
- Track research staff training, delegation logs, certifications, licenses, and onboarding requirements.
- Contribute to regulatory SOPs, templates, trackers, and workflows.
- Explain regulatory requirements and coordinate communication among investigators, research coordinators, sponsors, IRBs, monitors, and organizational leadership.
- Attend study team meetings and report on regulatory status, missing documents, and upcoming deadlines.
- Promote compliance, research integrity, and participant protection.
Requirements
- Bachelor’s degree preferred in health sciences, public health, healthcare administration, regulatory affairs, life sciences, or a related field.
- Experience in clinical research, regulatory affairs, compliance, IRB coordination, or healthcare administration.
- Understanding of human-subjects protections, IRB procedures, informed consent, and regulatory documentation.
- Strong organizational and document-management abilities.
- Exceptional attention to detail with the ability to manage multiple deadlines.
- Clear, effective written and verbal communication skills.
- Proficiency with Microsoft Office, Adobe, shared drives, electronic regulatory systems, and document-tracking tools.
- Clinical trials, academic research, FQHC-based research, or community-based research experience preferred.
- Familiarity with FDA regulations, Good Clinical Practice, HIPAA, and institutional review board requirements.
- Experience using electronic regulatory platforms or IRB systems preferred.
- Regulatory Affairs Certification, Certified IRB Professional, or clinical research certification preferred but not required.
- Experience preparing for sponsor monitoring visits, IRB audits, or regulatory inspections.
- Commitment to ethical research practices, participant protection, and applicable policies and regulations.
- Ability to work respectfully with diverse communities, patients, staff, investigators, and external partners.
- Ability to maintain accurate records and communicate promptly.
Benefits
- Local travel, evening work, or flexible scheduling may occasionally be required based on study needs.
- Participation in training, team meetings, quality-improvement activities, and performance reviews.
- Equal opportunity employment.