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IRB Specialist I, Center for Clinical Research
University Hospitals. Maintain current understanding of federal, state, and local laws, regulations, and guidelines governing human subject research .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in human subject research compliance, including knowledge of federal, state, and local regulations. Proficient in coordinating IRB processes and maintaining accurate documentation while ensuring the protection of health information.
Highest-signal resume keywords
Bachelor's Degree In Health SciencesIRB ExperienceKnowledge Of Research RegulationsCertification In Human Subjects Protection (CITI)1+ Years Experience In Research Administration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Knowledge Of Medical Concepts And TerminologyAccurate Typing SkillsAbility To Prioritize And Process IRB SubmissionsProficient In MS Office SoftwareAbility To Safely Maintain PHI
Soft Skills
Excellent Organization SkillsAbility To Work Independently And In A TeamService-OrientedSelf-MotivatedAttention To Detail
Certifications & Qualifications
Certification In Human Subjects Protection (CITI)Research Certification
Industry Keywords
Human Subject ResearchIRB PoliciesNIH GuidelinesDHHS GuidelinesOHRP GuidelinesFDA Guidelines
About the role
Key responsibilities & impact- Maintain current understanding of federal, state, and local laws, regulations, and guidelines governing human subject research
- Review human research protocol submissions for compliance with IRB policies, institutional SOPs, applicable rules, regulations, and ethical principles
- Coordinate IRB meetings, including preparing agendas and materials
- Record medical and ethical issues discussed to ensure accurate documentation of IRB determinations
- Serve as liaison among IRB committees, investigators and designees, and Center for Clinical Research and Technology staff
- Participate in special projects
- Perform other duties as assigned
- Comply with organizational policies and standards
- Safely and securely maintain Protected Health Information (PHI)
Requirements
What you’ll need- Bachelor's Degree in health sciences, bioethics or a related degree (Required)
- 1+ years prior experience in research, research administration, regulatory affairs, clinical and/or laboratory research (Required)
- IRB experience (Preferred)
- Knowledge of medical concepts and terminology
- Accurate typing skills
- Ability to articulate information in grammatically correct written form
- Excellent organization skills with attention to detail
- Ability to work independently and in a team setting and meet deadlines
- Good attendance record
- Service-oriented, self-motivated, professional, discrete, and act with integrity
- Knowledge of research regulations (Preferred)
- Understanding of current NIH, DHHS, OHRP, and FDA guidelines governing human subjects' research
- Ability to perform multiple duties simultaneously and manage occasional increased workload volumes
- Ability to prioritize and process IRB submissions efficiently
- Proficient in PC and all MS Office software
- Certification in Human Subjects Protection (CITI) required within 30 days
- Research certification (Preferred)
- Ability to safely and securely maintain Protected Health Information (PHI)
Benefits
Comp & perks- Full-time regular employment
- Hybrid work arrangement
- Day shift
- Annual training
- 10% travel