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Responsible for coordinating and reviewing caseload of applications related to human subjects research projects submitted for Institutional Review Board (IRB) analysis, maintaining the data archiving system and supporting the research community.
Responsibilities
- Understands and applies the Federal Regulations for human research to all project applications submitted for category determination and each level of IRB review (pre-review, re-review, clarifying issues, post meeting, Non-committee review) to ensure adherence to regulatory and ethical standards.
- Attends Board meetings, assists in the preparation of Board meeting by setting up agendas, assignment of reviewers, and related materials to be distributed to Board members or Chairs, monitors quorum at meetings and tracks IRB attendance and assists to facilitate discussion related to determinations made by the Board.
- Composes and distributes correspondence to investigators on behalf of the Board, Directors, or Chairs.
- Maintains documentation and records in accordance with departmental policies and procedures and ensures that all records are secured and properly archived.
- Maintains computerized database for tracking purposes. Enter or update database for complete submissions to PPHS
- Conceptualizes and can formulate the complexity of a project and provide guidance on next steps while integrating the PPHS Programs values and objectives with the overall objective of making the process easier for processing.
- Consults on project development and design, consent processes, and data storage solutions to facilitate quality science in the construct of the Federal Regulations and Institutional policies.
- Independently decides on project determinations and acts as the non-committee reviewer for the majority of projects reviewed while also utilizing the office non-committee reviewer process as well.
- Conceptualizes the steps necessary for final resolution of work/projects and follows through with appropriate steps to deliver final project approval/determination within office metric requirements.
- Serves as a resource on general regulatory information and provides guidance about forms and submission procedures and prioritizing work.
- Prepares weekly and monthly production metrics and reports for Senior Leadership.
- Independently integrates office data into reporting for other Research Administration offices (GCO/FCOIC/OCCT, etc.) and is able to discuss the complexities and nuances of the data with those offices, the research community, and PPHS office.
- Assesses level of review needed to process work assigned to staff.
- Provides expertise for development of staff and IRB members; prepares and teaches departmental in-services and assists with educational presentations to the research community.
- Serves as a resource in making project regulatory determinations and may make final determinations.
- Serves as an IRB member, may attend Board meetings, facilitates resolution of controverted issues, and assists in the preparation of minutes and post-meeting communication with researchers.
- Participates in the quality assurance review of analyst work and assists in resolving related issues.
- Actively engages in the negotiation and resolution of researcher complaints and solves problems/issues in a timely manner.
- Must have a strong understanding of Institutional policies and strong working knowledge of PPHS SOPS to assess status of projects due for submission renewals. Create reminder letters for researchers. May negotiate with research teams on timing of submissions.
- Must have a strong understanding of Institutional policies and strong working knowledge of PPHS SOPS to assess status of projects where research teams have failed to submit required paperwork (continuation/emergency use, etc.). Require notifying other Research Administrative offices of expirations and possible non-compliance.
- Independently review an average of 900 project submissions annually.
- Performs other related duties.
- Bachelors degree in health sciences or related field; Masters preferred.
- 4+ years of direct IRB Analyst experience required.
- Name: Certified IRB Professional Certification (CIP)
Strength Through Diversity
The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai's unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:
- Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.
- Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.
- Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.
At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization. We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally.
Explore more about this opportunity and how you can help us write a new chapter in our history
"About the Mount Sinai Health System:
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 14 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.
The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism."
EOE Minorities/Women/Disabled/Veterans
