Senior IRB Reliance Manager
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Job Location:
New York City, NY - USA
Yearly Salary:
USD 124295 - 147801
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title: Senior IRB Reliance Manager
Grade: 31
Salary: $124295 - $147801
The Research Foundation for Mental Hygiene is seeking a qualified candidate to fill a full-time Senior IRB Reliance Manager position under New York Psychiatric Institute (NYSPI) for Human Research Protection Program (HRPP). Under the supervision of the NYSPI IRB Director and Associate Director of the Human Research Protection Program (HRPP) the NYSPI Senior Institutional Review Board (IRB) Reliance Manager will work to oversee implement and manage all aspects of the NYSPI IRB reliance program. This critical role ensures that multi-site and cooperative human research is conducted efficiently ethically and in full compliance with all federal regulations state laws and institutional policies. The Senior IRB Reliance Manager will be the primary liaison between NYSPI and external IRBs and research partners driving excellent in the NYSPI Human Research Protection Program (HRPP).
This is a full-time position requiring on-site presence.
Duties and Responsibilities:
Program Management and Oversight:
- Direct all operational and administrative activities of the NYSPI IRB reliance program serving as a subject matter expert for reliance agreements (e.g. Institutional Authorization Agreements (IAA) Individual Investigator Agreements (IIA) Cooperative Research Agreements SMART IRB etc.)
- Develop implement and continuously refine institutional policies and Standard Operating Procedures (SOPs) for both ceding and serving as the Single IRB (sIRB) of record.
- Monitor the effectiveness and efficiency of the reliance processes identifying and implementing enhancements to streamline multi-site and cooperative review while maintaining rigorous compliance and ensuring ethical conduct of research.
- Stay current on evolving federal regulations (e.g. 45 CFR 46 FDA regulations NIH Single IRB Policy) state laws and best practices related to cooperative research and IRB reliance.
Minimum Qualifications:
- Bachelors degree in a relevant field (e.g. philosophy research ethics research administration law or related).
- Minimum of (5) years of progressively responsible experience in IRB administration research compliance or a related regulatory field with at least (3) years of specific experience managing IRB reliance agreements for multi-site research.
- Comprehensive knowledge of federal regulations governing human subjects research (e.g. 45 CFR 46 including the Revised Common Rule and FDA regulations).
- Strong organizational skills attention to detail and ability to manage multiple complex tasks simultaneously in a deadline-driven environment.
Preferred Qualifications:
- Advanced degree and (8) years of experience in an IRB or Human Research Protection Office.
- (3)-(5) years of experience in a supervisory or management role within an HRPP.
- (3)-(5) years of experience with OneAegis or a similar electronic IRB management system.
- (3)-(5) years of demonstrated experience negotiating and executing IRB reliance agreements including familiarity with SMART IRB.
- Excellent written and verbal communication negotiation and interpersonal skills with the ability to effectively communicate.
Work Location: 1051 Riverside Drive New York NY 10032
To Apply: Submit an application through our website at Please note only applications submitted through our website will be considered.
The Mission of the Research Foundation for Mental Hygiene Inc. (RFMH) is to promote the mental health of all New Yorkers with a focus on providing hope and supporting recovery for adults with serious mental illness and children with serious emotional disturbances. Applicants with lived mental health experience are encouraged to apply. RFMH is deeply committed to supporting underserved individuals organizations and communities. To this end RFMH is focused on implementing activities and initiatives to reduce disparities in access quality and treatment outcomes for underserved populations. A critical component of these efforts is ensuring that RFMH is a diverse and inclusive workplace where all employees unique attributes and skills are valued and utilized to support the mission of the Agency. RFMH is an equal opportunity/affirmative action employer.
The Research Foundation is a private not-for-profit corporation and is not an agency or instrumentality of the State of New York. Employees of the Research Foundation are not state employees do not participate in any state retirement system and do not receive state fringe benefits. Excellent Benefits Package. Affirmative Action/Equal Opportunity Employer - Disabled/Veteran 41 CFR 60-741.5(a) and 41 CFR 60-300.5(a) compliant.
Required Experience:
Manager
Key Skills
- Program Management
- FDA Regulations
- Management Experience
- Facilities Management
- Clinical Development
- Data Management
- Quality Systems
- Project Management
- Research & Development
- GLP
- Budgeting
- Leadership Experience
About Company
The Research Foundation for Mental Hygiene connects scientists and supporters. RFMH is responsible for administering grants and sponsored research contracts for the New York State Department of Mental Hygiene and its agencies. It administers more than $60 million annually. The foundat ... View more
