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Responsible for coordinating and reviewing caseload of applications related to human subjects research projects submitted for Institutional Review Board (IRB) review, maintaining data archiving system and supporting researcher community.
Duties and 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
- Maintains computerized database for tracking purposes. Enters or updates database to document submissions to PPHS and actions required
- Maintains documentation and records in accordance with departmental policies and procedures and ensures that all records are secured and properly archived
- Checks to ensure PPHS education requirements, FCOIC and GCO submissions are complete before submissions can be accepted for review. Rejects submissions due to missing requirements and notifies research teams
- Assists in making project regulatory determinations
- Acts as a liaison between the IRB and the research community and responds to queries
- Prepare and upload agenda packets for IRB members and consultants
- Acts as the main contact between IRB members and the PPHS office. Collects and manages attendance, and IRB reviews from IRB members. Compiles members’ comments for meetings and enters comments into database for meeting agenda/Board review
- Composes and distributes correspondence to investigators on behalf of the Board, Directors, or Chairs
- Is familiar with all submissions placed on the agenda for a convened IRB meeting
- Acts as the liaison with all other Research Administration offices related to a human research project
- Prepares meeting minutes of all action plans and discussions per office policies
- 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
- Independently reviews an average of 500 project submissions annually
- Performs other related duties
- Bachelor’s degree in health sciences or related field
- 0- 2 years experience
- Strong written and oral communications skills
- Excellent interpersonal skills
- Excellent organization skills
- Attention to details
- Knowledge of the federal regulations governing human-subjects research is preferred
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.