Director of the Clinical Research Support Unit jobs in United States
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NYU Langone Health · 11 hours ago

Director of the Clinical Research Support Unit

NYU Langone Health is a top-ranked medical institution committed to improving the human condition through education and research. The Director of the Clinical Research Support Unit provides strategic leadership and operational management to enhance clinical research activities, ensuring compliance and fostering innovation in research processes.

EducationHealth CareHospitalMedicalNon Profit
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

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
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
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)
Develop and manage the CRSU budget, ensuring efficient resource allocation
Formulate and administer the annual operating budget, managing resources to accomplish specified goals and objectives
Develop and monitor key performance indicators (KPIs) to track the progress and success of the CRSU
Identify opportunities for process improvement, implementing strategies to enhance faster times to activate studies
Lead and manage a team of clinical research professionals (i.e., managers and specialists), providing guidance, and performance management
Directs the efforts of CRSU staff, setting performance standards and accountability
Prepares analyses for immediate and long-range resource management planning, while ensuring efficient operations with existing resources
Serve as Business owner of the Clinical Research Management System (CRMS) and work closely with Medical Center IT to ensure functionality and suitability for supporting submissions to CRSU
Perform other duties as specified by the Senior Director, RDI

Qualification

Advanced-Level LeadershipClinical Research ManagementBilling ComplianceClinical Practice (GCP)Change ManagementCTMS ExperienceProcess ImprovementSupervisory ExperienceProject ManagementAnalytical SkillsInterpersonal SkillsOrganizational SkillsTime ManagementWritten Communication

Required

Master's degree or equivalent in life sciences, public health, or a related field
Demonstrated Advanced-Level Leadership skills, including championing innovation, ability to deliver concise communication, handle crisis management effectively, and lead cross-functional teams to achieve shared goals
10+ years of experience working in a Clinical Research Organization (CRO), hospital or equivalent, medical center or academic medical setting, including 6+ years of demonstrated success leading enterprise-wide projects as a key decision-maker demonstrating decisive and persuasive leadership with executive presence
Demonstrates and models ownership through accountability and leadership by example that inspires trust with a focus on developing future leaders, ensuring continuity and organizational resilience
Strong presentation and writing skills. Must have progressive leadership experience. In-depth knowledge and understanding of Medicare Clinical Trials Policy (CTP), coverage analysis, billing compliance, Good Clinical Practice (GCP) and human subject research with ability to align strategies with unit objectives
Experience (7+ years) leading large complex programs in a matrixed organization with demonstrated director level experience leading these programs with clear markers of success that lead the program to grow and meet strategic goals
Supervisory and management experience, including management of indirect reports in a matrixed environment
Ability to simultaneously conceive, manage, execute, and coordinate multiple projects within tight timelines and budget parameters

Preferred

Strong knowledge of Change Management with advanced knowledge and proficiency in project management methodologies and tools
Ability to work effectively and lead within matrixed organizational and cross functional project teams
Ability to transform and nourish a positive and inclusive workplace culture, driving engagement and organizational success
A Masters Degree
Academic medical center experience
Process improvement experience
CTMS experience
Billing Compliance experience
Competencies: Action oriented, Functional/technical skills, Interpersonal skills, Organizational skills, Analytical skills, Time management, and Written communications. Respects diversity

Benefits

Comprehensive benefits and wellness package
Financial security benefits
Generous time-off program
Employee resources groups for peer support
Holistic employee wellness program

Company

NYU Langone Health

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NYU Langone Health is a nonprofit organization that provides a center of excellence in healthcare, research, and medical education.

H1B Sponsorship

NYU Langone Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (5)
2021 (8)
2020 (35)

Funding

Current Stage
Late Stage
Total Funding
$33.5M
Key Investors
National Institute of Diabetes and Digestive and Kidney DiseasesMHCIPNational Institutes of Health
2024-02-06Grant· $13M
2023-10-16Grant· $12.5M
2022-02-17Grant· $8M

Leadership Team

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Suresh Srinivasan M.Tech, MBA
Vice President & Chief Technology Officer
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Robert Cerfolio, MD, MBA
Executive vice president COO
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Company data provided by crunchbase