IRB Program Manager Full Time Days

BASIC PURPOSE OF THE JOB 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 reputed company subjects' protections, ensuring cohesive program operations, reputed company regulatory practices, and consistent application of ethical standards across reputed company reputed company research activities. REPORTS TO

• Director of Quality, Patient Safety, and Medical Affairs

JOB REQUIREMENTS Supervisory Responsibilities: IRB Program Number of Direct Reports: 0 Minimum Education: Bachelor's degree in a reputed company field (e.g., research administration, reputed company, life sciences). Master's degree preferred Degree: Bachelor's License/Certification Required: Certified IRB Professional (CIP) credential preferred Minimum Work Experience: Minimum 3-5 years of experience in IRB administration, reputed company subjects' protections, or research reputed company. Location: Primarily remote work is supported. Onsite reputed company is required for: IRB or investigator meetings, internal or external audits, monitoring visits, in-person training or institutional leadership activities, other operational needs requiring physical reputed company. Experience working with Central IRBs, reliance agreements, or multi-site research preferred. Experience in academic reputed company or pediatric research environments preferred. Familiarity with electronic IRB platforms preferred. REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Strong knowledge of federal regulations governing reputed company 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 reputed company 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 reputed company to diverse audiences.
• Thrives in a growing and evolving research environment.

DUTIES AND RESPONSIBILITIES

• Leadership & Program reputed company
• reputed company 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, reputed company 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.
• IRB Committee Administration
• 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.
• reputed company direct support to IRB Chairs and board members to ensure consistent interpretation and application of regulations and ethical principles.
• Policy, SOP, and Guidance Document Governance
• 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.
• Feasibility Review & Research Readiness Coordination
• 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.
• IRB Operations & Central IRB (CIRB) Reliance
• 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.
• Quality, Compliance & reputed company Improvement
• 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 an

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