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Institutional Review Board Coordinator
Mercyhealth Wisconsin and Illinois. Provide regulatory expertise, guidance and administrative support to the Institutional Review Board reviewing human subject research protocols .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory compliance and guidance for human subject research, with strong skills in document review, communication, and organizational support for Institutional Review Board processes.
Highest-signal resume keywords
Regulatory ExpertiseHuman Subject ResearchCIP CertificationGCP CertificationFederal Regulations Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Document ReviewResearch Proposal ProcessingInformed Consent ReviewData AnalysisMicrosoft Office ProficiencySpreadsheet Software KnowledgeDatabase Software Knowledge
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationAttention to DetailProblem SolvingCritical Thinking
Certifications & Qualifications
CIP CertificationGCP Certification
Industry Keywords
Institutional Review BoardHuman Subject Research ProtocolsRegulatory EnvironmentPolicies and ProceduresCompliance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide regulatory expertise, guidance and administrative support to the Institutional Review Board reviewing human subject research protocols
- Serve as the primary regulatory resource for investigators and staff
- Educate, consult and guide researchers and staff in the design and conduct of human subject research
- Provide guidance regarding procedural requirements for processing research proposals
- Review new research applications for consistency, completeness and compliance
- Review protocol and amendment documents and federally mandated informed-consent elements
- Communicate clarification items and required submission documents to Principal Investigators
- Prepare written correspondence documenting IRB determinations and required revisions
- Evaluate unanticipated problems, noncompliance, amendments and continuing review forms and prepare recommendations
- Educate and guide IRB members on applicable regulations, policies and SOPs
- Assist in developing, recommending and implementing policies and procedures
- Monitor the regulatory environment and recommend changes to the IRB
- Prepare agendas, meeting materials and minutes, and maintain accurate IRB files
- Perform under the Manager of Research, Ethics and Chaplaincy
- No supervisory responsibilities
Requirements
What you’ll need- Bachelor's degree in biomedical, health science, social sciences or related field is required
- Experience in healthcare or directly related to human subject research is required
- Knowledge of the federal regulations and guidelines that govern the conduct of research involving human subjects is required
- Moderate level of experience using Microsoft Office products is required
- CIP certification required to be obtained and maintained upon meeting eligibility criteria
- GCP certification required to obtained and maintained upon meeting edibility criteria
- Ability to interpret and apply laws and regulations
- Excellent written and verbal skills
- Attention to detail and extensive organization skills
- Excellent problem solving, reasoning and critical thinking skills
- Excellent typing and word processing skills
- Excellent knowledge of spreadsheet and database software
- Ability to sit and talk or hear; occasionally stand and walk; occasionally lift and/or move up to 25 pounds
- Ability to adjust focus and close and distance vision
Benefits
Comp & perks- Medical, Dental, Vision
- Life & Disability Insurance
- FSA/HSA Options
- Generous, accruing paid time off
- Paid Parental and caregiver leave
- Career advancement and educational opportunities
- Tuition and certification reimbursement
- Certification Reimbursement
- Well-being Programs
- Employee Discounts
- On-Demand Pay
- Financial Education
- Annual recognition/awards events
- Partner appreciation days
- Family entertainment/attractions discount
- Community service/improvement opportunities