Manager - Human Research Protection Office

Presbyterian Healthcare Services • New York, NY

34d • $72,134 - $110,136 • Onsite

About The Position

Build your Career. Make a Difference. Presbyterian is hiring a skilled Mgr-Human Research Protection Office (HRPO) will promote, expand, and manage the functions of the IRB operation, compliance, and research study oversight. This position will act as a liaison between Presbyterian Healthcare Services IRB, industry sponsors, and the various Presbyterian partners. The IRB Manager will assist in reviewing and facilitating IRB approval, and ensure effective and timely reporting, including exchange of regulatory correspondence and metrics related to research.

Requirements

• In-depth understanding and knowledge of 45 CFR 46, 21 CFR 56, 21 CFR 50, and other applicable regulatory requirements within human subject research.
• Excellent management skills with high adaptability.
• Strong collaborative management style.
• Leadership skills to align with overall organizational vision, purpose, and strategy.
• Excellent communication skills to adapt to various target audiences.
• Knowledge of process improvement tools and processes.
• Master of Science degree and three years of relevant experience, or combination of education and relevant experience.
• Three years of experience in clinical research required.
• Comprehensive knowledge of regulatory information regarding the use of human/animal participation in research and teaching.
• Demonstrated understanding of the principles of human/animal research protection standards.
• Strong knowledge of grants and contracts functions.
• Significant working knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management.
• In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
• Demonstrated strong verbal and written communication skills.
• Knowledge of human/animal subject federal and state laws and guidelines.

Nice To Haves

• Experience functioning as a one-person HRPP office.
• Familiarity with OneAegis or other IRB/HRPP management systems.
• Experience with cIRB reliance workflows.
• Experience in clinical research compliance, quality assurance, or regulatory affairs.
• 10+ years of experience in research regulatory and HRPO

Responsibilities

• Developing, implementing, and managing efficient procedures to facilitate the processing of human subject research protocol in accordance with institutional, State, Federal, and possibly accreditation bodies policies and procedures.
• Planning and coordinating IRB review and follow-up activities.
• Serving as an expert liaison between the research investigator and the reviewer; education parties on relevant and emerging regulations and related risk management issues.
• Performing review of complex research protocols, including identifying problems and issues in the submission application, and contacting the investigator to request additional materials.
• Aiding the Presbyterian Human Research Protection Program (HRPP/Clinical Research) leadership in preparation for audits and possible accreditation and in various compliance and quality assurance activities.
• Protocol Evaluation and management: Review and evaluate research protocols, modifications, continuing reviews, and event reports for approval based on applicable research laws, regulations, and guidelines.
• Correspond with researchers to ensure applications are clear and complete.
• Ensure the IRB staff is processing all submissions in a timely manner in order to meet deadlines and workflow standards.
• Knowledge on the use of electronic submission platforms and data management systems.
• Use electronic submission and data management systems with accuracy to track submissions and retain documentation in accordance with policy and regulation.
• Develop and maintain good working relationship with members of the research community.
• Review of current program processes for workflow and effectiveness optimization.

Benefits

• All benefits-eligible Presbyterian employees receive a comprehensive benefits package that includes medical, dental, vision, short-term and long-term disability, group term life insurance and other optional voluntary benefits.
• Presbyterian's Employee Wellness rewards program is designed to provide you with engaging opportunities to enhance your health and activate your well-being. Earn gift cards and more by taking an active role in our personal well-being by participating in wellness activities like wellness challenges, webinar, preventive screening and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees