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 research administration (ERA) vendor to customize the IRB submission module for use at Northwell.
   5. Works closely with Research Intelligence leadership to define strategic priorities and guide decision-making.
   
   
2. Operational Leadership:
   
   
   
   1. Provides administrative oversight, strategic problem-solving, and regulatory guidance for collaborative review of complex research including but not limited to, pragmatic clinical trials, implementation science and research developing and using artificial intelligence.
   2. Provides guidance on appointment of IRB committee members in compliance with federal, state, and local regulations as well as institutional needs.
   3. Once established, directs the daily operation of IRB administrative office, specifically planning, organizing and supporting the IRB review process for research protocols; Provides regulatory guidance to the IRB Chair and IRB Members.
   4. Develops, maintains and continuously improves policies and standard operating procedures to ensure efficient and compliant IRB operations.
   5. Designs and implements quality assurance and post approval monitoring activities;
   6. Advises Investigators and other research staff of appropriate conduct of research, preparation of protocol and consent documents in accordance with applicable regulations and reporting requirements for human subject research.
   7. Maintains official IRB records, e.g. IRB meeting minutes, schedules and roster, in accordance with regulatory requirements.
   8. Evaluates, recommends and implements educational programs for IRB members, IRB administrative staff and the research community.
   9. Actively engages in ongoing learning to stay current with evolving policies, regulations, and procedures in human research oversight.
   
   
3. Relationship Management:
   
   
   
   1. Builds and maintains productive inter/intra departmental, Northwell clinical service line, partner institutions, and regulatory agency work relationships to optimize operations; partners with the Research Intelligence leadership team to optimize IRB submissions with overall organizational endeavors.
   2. Serves as liaison to Northwell center heads and departments to ensure positive service orientation for the office Ensures active and transparent communication.
   3. Partners with research and corporate compliance in identifying "for cause" audits and problem resolution for events that require reporting to federal and state agencies.
   4. Serves as a liaison to federal and NY State agencies and committees, which regulate human subject research, as required.
   
   
4. Team Management:
   
   
   
   1. Oversees and evaluates the team who provides IRB review services to the research community.
   2. Oversees the selection, development, management and evaluation of direct reports.
   3. Provides administrative oversight and problem resolution guidance.
   4. Develops and implements an organizational plan to support the accomplishment of long-range objectives and career development of those team members through establishment of individual learning plans and performance measures.
   5. Develops and provides training programs for staff to keep up to date on funder requirements.
   6. Actively pursues and shares knowledge about policies, regulations, and procedures
   
   
5. Budget Management:
   
   
   
   1. Prepares operating budget for approval.
   2. Responsible for day-to-day management of Research Intelligence administrative IRB office budget.
   
   
6. Data Integrity and Reporting:
   
   
   
   1. Implements quality control processes to monitor data accuracy of the ERA (IRB submission system).
   2. Identifies key performance indicators related to efficient and effective IRB review and develops and reports on the identified metrics for IRB activities to the organization.
   3. Prepares and submits reports to federal and state agencies regarding IRB decisions and research compliance issues as required by regulation.
   4. Provides regular and ad hoc reports to leadership.
   
   

Preferred Qualifications

• Certified IRB Professional (CIP) certification.
• Strong organization skills, attention to detail, and written and oral communication.
• Demonstrated ability to manage multiple competing priorities and deadlines, analyze complex situations, shift approaches/priorities, and develop actionable solutions.
• Expert knowledge of regulations governing research with humans, including but not limited to DHHS, FDA, and DoD.
• Knowledge of and experience with electronic data management systems.
• Knowledge of HIPAA regulations and state laws governing privacy and security of protected health information.

*Additional Salary Detail
The salary range and/or hourly rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future.When determining a team member's base salary and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget and internal equity).