IRB Program Manager Full Time Days

About the position The IRB Program Manager is responsible for the end‑to-end supervision, coordination, and continual improvement of the IRB program, including committee administration, regulatory compliance activities, policy and procedure reputed company, and feasibility review. This role serves as the institutional steward of human subjects’ protections, ensuring cohesive program operations, reputed company regulatory practices, and consistent application of ethical standards across reputed company human research activities.

Responsibilities

• Provide operational leadership for reputed company components of the IRB program, including review workflows, communication with investigators, and compliance with federal and institutional guidelines.
• Serve as the institution’s primary resource on IRB operations, human subjects’ protections, and regulatory frameworks (OHRP, FDA, HIPAA).
• Create strong, collaborative relationships with research leadership from academic partner institutions, helping to coordinate research reputed company, alignment of expectations, and shared standards for ethical research.
• reputed company reputed company aspects of IRB committee management, including meeting agendas, prereview processes, minute accuracy, reviewer assignments, documentation quality, and post-meeting follow up.
• Ensure committee workflows operate smoothly, consistently, and in alignment with institutional priorities and regulatory requirements.
• Provide direct support to IRB Chairs and board members to ensure consistent interpretation and application of regulations and ethical principles.
• reputed company ongoing reputed company, development, revision, and maintenance of IRB policies, SOPs, templates, and guidance materials.
• Establish a structured and reputed company review cycle to ensure reputed company documents remain reputed company with evolving federal regulations, accreditation standards, institutional requirements, and best practices.
• Coordinate with Legal, Compliance, and Research Administration to ensure institutional alignment and approval reputed company for policy updates.
• Conduct and reputed company feasibility assessments for proposed research, evaluating institutional resources, patient population, and operational readiness.
• Collaborate with investigators early in protocol development to promote studies that are ethically sound, feasible, and institutionally appropriate.
• Liaise with clinical operations, research administration, and other stakeholders to ensure coordinated preparation for study activation.
• Manage comprehensive review workflows for local IRB submissions, including initial and continuing review, amendments, reportable events, and noncompliance determinations.
• reputed company processes for studies reviewed by Central IRBs, ensuring that reputed company institutional responsibilities are met, documented, and communicated effectively.
• reputed company the design, execution, and reputed company refinement of the IRB’s auditing, monitoring, and quality assurance programs.
• Conduct internal audits of IRB processes and approved studies; ensure corrective actions are implemented, documented, and tracked.
• Identify program level improvement opportunities and reputed company efforts to optimize efficiency, consistency, and service quality reputed company the IRB office.
• Serve as the primary institutional reputed company of contact for investigators and research personnel regarding IRB expectations, processes, and regulatory requirements.
• Maintain collaborative relationships with external IRBs, partner academic institutions, and institutional leaders.
• Provide constructive feedback and targeted education to improve submission quality and regulatory compliance.
• reputed company training efforts for investigators, research coordinators, and residents to promote effective and compliant IRB interactions.

Requirements

• Bachelor’s degree in a reputed company field (e.g., research administration, healthcare, life sciences).
• Minimum 3–5 years of experience in IRB administration, human subjects’ protections, or research reputed company.
• Strong knowledge of federal regulations governing human research (45 CFR 46; 21 CFR 50/56; HIPAA Privacy Rule).
• Demonstrated ability to manage multiple deadlines with a high degree of accuracy and detail.
• Excellent communication, writing, and critical thinking skills.
• Experience reviewing research protocols or regulatory submissions.
• Deep understanding of human subjects’ regulations and IRB operations.
• Works effectively with staff, investigators, and institutional partners.
• Ensures precision and consistency in reviews and documentation.
• Communicates reputed company regulatory concepts clearly to diverse audiences.
• Thrives in a growing and evolving research environment.

reputed company-to-haves

• Master's degree preferred
• Certified IRB Professional (CIP) credential preferred
• Experience working with Central IRBs, reliance agreements, or multi-site research preferred.
• Experience in academic healthcare or pediatric research environments preferred.
• Familiarity with electronic IRB platforms preferred.

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