Specialist III, Research Compliance - Institutional Review Board

Tecnical Summary; New Protocol & Risk Review: Conducts in-depth, independent pre-reviews of complex, high risk biomedical, clinical, and socio-behavioral research protocols, including consent form documents and determinations (e.g., research vs non-research). Evaluates ethical considerations and assesses risks and benefits, particularly for vulnerable populations. Reliance & Single IRB (sIRB): Leads reliance agreement negotiations, manages external IRB partnerships, and coordinates multi-site communication strategies ensure regulatory alignment and compliance. Investigator Support and Consultation: Serves as a resource to Principal Investigators and study teams, providing expert guidance on new protocol submissions, informed consent language, and cede review reliance process .Post-Approval Monitoring: Supports the continuing review and modification process and evaluates unanticipated problems

Job Summary:

Leads the development, revision, implementation, and communication of complex policies, procedures, processes, and guidelines. Provides expertise and guidance on incorporating best practices and recommendations into changes to processes, systems, and workflows for operational improvements. Partners with internal and external stakeholders to provide oversight, coordination, and ongoing monitoring of identified studies to ensure remediation. Advises advice to staff and stakeholders on regulatory and/or compliance requirements, policies, and procedures governing research and documents regulatory and/or compliance decisions for research activities. Delivers education and training events, sessions, programs, and/or initiatives and leads the development of materials. Leverages data and metrics to assess effectiveness, identify critical gaps, and recommends action plans to improve education and training programs.

Essential Responsibilities:

• Promotes learning in others by communicating information and providing advice to drive projects forward; builds collaborative, cross-functional relationships. Solicits and acts on performance feedback; provides actionable feedback to others, including upward feedback to leadership; influences, mentors, and coaches team members. Practices self-leadership; creates, evaluates, and responds to the strengths and weaknesses of self and unit or team members. Leads the adaptation to competing demands and new responsibilities; adapts to and learns from change, challenges, and feedback. Fosters open dialogue amongst team members.
• Drives the execution of multiple work streams by identifying member and operational needs; translates business strategy into actionable business requirements; develops and updates new procedures and policies. Gains cross-functional support for objectives and priorities; determines and carries out processes and methodologies; solves highly complex issues; escalates and resolves issues as appropriate; sets standards and measures progress. Develops work plans to meet business priorities and deadlines; coordinates, obtains and distributes resources. Removes obstacles that impact performance; guides performance and develops contingency plans accordingly; influences the completion of project tasks by others.
• Establishes and maintains research policy by: leveraging expert knowledge of federal, state, and local regulations, ethical issues, and organizational policies; determining and advising on the impact of emerging regulations and statutes and providing recommendations for policy updates; and leading the development, revision, implementation, and communication of complex policies, procedures, processes, and guidelines.
• Supports ongoing quality monitoring and improvement by: providing expertise and guidance on incorporating best practices and recommendations into processes, systems, and workflows and driving implementation of operational improvements; serving as an expert on the analysis and reporting of research activities and mentoring others on identifying trends and/or potential issues, addressing issues as necessary; leading the development, implementation, and management of programmatic quality improvement and/or monitoring initiatives and the creation of materials (e.g., worksheets, checklists); and partnering with internal and external stakeholders to provide oversight, coordination, and ongoing monitoring of identified studies to ensure remediation.
• Drives research compliance by: providing expertise and advice to staff and stakeholders on regulatory and/or compliance requirements, policies, and procedures governing research and documenting regulatory and/or compliance decisions; serving as an escalation point for continued and complex noncompliance (e.g., protocol deviations and/or violations, reportable events, adverse events, serious adverse events, unanticipated problems); providing recommendations and developing targeted corrective action plan(s); and acting as a point of contact for internal and external stakeholders during inspections and/or audits and communicating findings across teams.
• Facilitates the continuous education of research personnel by: delivering education and training events, sessions, programs, and/or initiatives and providing expertise and leading the development of materials and documentation; leveraging and translating education and training effectiveness data and metrics to identify critical gaps and deficiencies and recommend action plans to address them; and maintaining subject matter expertise and incorporating best practices to drive education and training program improvements.

Knowledge, Skills and Abilities: (Core)

• Ambiguity/Uncertainty Management
• Attention to Detail
• Business Knowledge
• Communication
• Critical Thinking
• Cross-Group Collaboration
• Decision Making
• Dependability
• Diversity, Equity, and Inclusion Support
• Drives Results
• Facilitation Skills
• Health Care Industry
• Influencing Others
• Integrity
• Learning Agility
• Organizational Savvy
• Problem Solving
• Short- and Long-term Learning & Recall
• Teamwork
• Topic-Specific Communication

Knowledge, Skills and Abilities: (Functional)

• Audits
• Business Process Improvement
• Compliance Management
• Confidentiality
• Consulting
• Good Clinical Practices (GCP)
• Health Care Compliance
• Health Care Policy
• Maintain Files and Records
• Managing Diverse Relationships
• Quality Assurance and Effectiveness
• Regulatory Reporting
• Research Ethics
• Risk Assessment
• Risk Management
• Stakeholder Management
• Trend Analysis

Minimum Qualifications:

• Minimum five (5) years of experience in a leadership role with or without direct reports.

• Bachelors degree in Health Science, Public Health, Law, Social/Physical/Life Science, or related field AND minimum nine (9) years of experience in research compliance, human subjects research, research design, research operations, research data management, or a directly related field OR Minimum twelve (12) years of experience in research compliance, human subjects research, research design, research operations, research data management, or a directly related field.

Preferred Qualifications:

• Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS); Certified Healthcare Compliance, Certified Healthcare Privacy Compliance, Certified Healthcare Research Compliance from the Healthcare Compliance Association (HCCA); or Certified IRB Professional.
• Four (4) years of experience with project management.