Ground breaking science. Advancing medicine. Healing made personal.
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.
- 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 Program’s 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.
- Bachelor’s degree in health sciences or related field; Masters preferred.
- Certified IRB Professional Certification (CIP) required.
- 4+ years of direct IRB Analyst experience required.
The Mount Sinai Health System believes that diversity is a driver for excellence. We share a common devotion to delivering exceptional patient care. Yet we’re as diverse as the city we call home- culturally, ethically, in outlook and lifestyle. 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 work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.
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Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.