Senior Director, Clinical Research (IRB)

Overview

We are seeking a highly skilled and experienced human subjects research administrator to lead the establishment and oversight of a new Institutional Review Board (IRB) and its supporting administrative office.  This critical role will support the development of a Northwell Health enterprise-wide, federally funded clinical research infrastructure, which is currently in its early stages of development.  The ideal candidate possesses in-depth knowledge of IRB administrative operations and extensive experience managing of a large portfolio of sponsored human research, as well as a flexible approach and deep understanding of human research regulations to ensure compliance with federal and state regulations. 

The Senior Director will be responsible for building the IRB and administrative framework from the ground up, with a strong emphasis on envisioning efficient and effective workflows that meet the needs of the research community, establishing policies and procedures for IRB review and using data driven metrics to identify opportunities for continuous improvement. Once launched, the candidate will work closely with IRB members, IRB staff and the research community to maintain high standards of research integrity and ethical principles. 

Job Description

Oversees clinical research activities to ensure goals and objectives are accomplished within prescribed time-frame and funding parameters. Oversees development and implementation as well as data collection and analysis; staff recruitment and management.

Job Responsibility

1.Leads  clinical research by communication with and developing staff members, and building consensus for programs and goals that support a business, function or geographic area. 
2.Develops and articulates a short-term  strategic vision for Clinical Research.
3.Leads a functional unit in multiple sites with larger portfolios by developing, communicating, and building consensus for goals/programs that support clinical research.
4.Initiates and develops strategic plans, policies and procedures for the program; identifies and develops initiatives and opportunities consistent with mission and strategic direction of the health system; establishes and measures performance against goals and objectives.
5.Develops, implements, and oversees clinical trial activities including the development of final research protocols, data management and trial management plans.
6.Implements strategic policies when selecting methods, techniques and evaluation criteria to obtain results.
7.Acts independently to resolve issues associated with the development and implementation of operational programs.
8.Plans and recommends programs to accomplish long-range objectives.
9.Exercises wide latitude of authority in determining objectives and approaches to critical assignments.
10.Regularly collaborates work with senior to executive leadership and those outside clinical and/or business area.
11.Develops and implements strategic plans, drives departmental and family goals and objectives, and improves performance across multiple sites or larger portfolios.
12.Responsible for directing staffing appropriately for department(s) and collaborating with HR to fulfill requirements13.Reviews and approves documents generated by clinical research including, but not limited to protocols, study reports and regulatory documents supporting Investigational New Drugs (INDs), New Drug Applications (NDAs) and Food and Drug Administration (FDA) information requests.
13.Prepares budget and recommends for approval.
14.Responsible for day-to-day management of budget for departments and families.
15.Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.

Job Qualification

1.Bachelor's Degree required, or equivalent combination of education and related experience Master's Degree, preferred.
2.8-12 years of relevant experience and 7+ years of leadership / management experience, required.

Key Responsibilities (Research Intelligence Specific)

1. Develop Administrative Infrastructure:
   1. Leads the design and implementation of the Research Intelligence IRB and administrative office infrastructure, including the establishment of office processes, workflow systems, collaborative tools for clinical research teams and appropriate federal assurance and registrations. 
   2. Reviews existing health system research policies, creating and amending as necessary. 
   3. Implements a hands-on approach to understanding the needs of the research community by directly engaging with investigators and administrators.
   4. Works with electronic