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) review, maintaining data archiving system and supporting researcher 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.
- 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.
3. 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.
- Serves as a resource in making project regulatory determinations and may make final determinations.
- 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.
- Composes and distributes correspondence to investigators on behalf of the Board, Directors, or Chairs.
- Serves as an IRB member, may attend Board meetings.
- Independently reviews an average of 700 project submissions annually.
- Performs other related duties.
- Bachelor’s degree in health sciences or related field; Masters preferred
- Certified IRB Professional (CIP)
- 3 years of direct IRB analyst (or equivalent) experience
- General Skills:
- Strong written and oral communications skills
- Strong interpersonal skills
- Excellent organization skills
- Intermediate Adobe Acrobat Standard/Professional
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.
Explore more about this opportunity and how you can help us write a new chapter in our story!
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.