Director Clinical Research Support Unit

Position: Director of the Clinical Research Support Unit
Job Description

NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care.

At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge.

For more information, go to med.nyu.edu, and interact with us on Linked In, Glassdoor, Indeed, Facebook, Twitter and Instagram.

Position Summary:

We have an exciting opportunity to join our team as a Director of the Clinical Research Support Unit.

The Director of the Clinical Research Support Unit (CRSU) provides strategic leadership and operational management to enhance clinical research activities supported by CRSU. This role involves developing and implementing strategic plans that align with organizational goals, focusing on billing compliance and reducing start-up time for activating clinical research studies. The Director leads initiatives to drive innovation and process improvements, translating business plans into operational plans with high-level judgment.

In team management, the Director oversees a team of managers and specialists, providing guidance and performance management, setting performance standards, and preparing analyses for efficient operations.

The Director ensures compliance with institutional policies, relevant regulations, including Good Clinical Practice (GCP) guidelines and FDA regulations, fostering a culture of compliance within the unit. Stakeholder management involves developing partnerships throughout NYULH and collaborating with internal and external stakeholders such as Contracts, Sponsored Programs Administration (SPA), Principal Investigators, sponsors, Clinical Research Organizations (CROs), and Institutional Review Boards (IRBs).

The Director advises department and division administrators on improving efficiencies with clinical research submissions to CRSU. Performance monitoring involves tracking key performance indicators (KPIs) to measure CRSUs success, identifying opportunities for process improvement, and implementing strategies to enhance faster study activation. The Director, Clinical Research Support Unit (CRSU) is a core leader that demonstrates Advanced-Level Leadership skills.

Job Responsibilities:

Strategic Planning and Leadership:

Develop and implement strategic plans for the Clinical Research Support Unit (CRSU), aligning them with organizational goals. Provide strategic leadership and vision for the CRSU, setting long-term objectives, enhancing the effectiveness of budget reviews, and reducing the start-up time for activating clinical research studies. The director will lead initiatives that drive innovation and process improvements across NYULH, translating business plans into operational plans with high-level judgment.

Policy and Guidelines

Develop, revise, and update institutional policies for clinical research budgeting to ensure compliance with all relevant regulations, including Medicare Clinical Trials Policy (CTP), Good Clinical Practice (GCP) guidelines, and FDA regulations.

Research Community and other Stakeholders Engagement

Meet with Principal Investigators, study staff, department leadership and administrators to review concerns, answer questions, and resolve any issues impacting the review of study budgets and overall study activation. Develop and maintain partnerships throughout NYULH by actively engaging and collaborating with internal and external stakeholders, including Contracts, Sponsored Programs Administration (SPA), Clinical Research Finance (CRF), MCIT, Principal Investigators, study teams, sponsors, Clinical Research Organizations (CROs), and Institutional Review Boards (IRBs).

Budget…