IT Technician

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

POSITION SUMMARY : We have an exciting opportunity to join our team as a Assistant Director, Clinical Research - Cardiology. Directs and oversees the clinical research function for the Cardiology Clinical Research Center (CCRC). Oversight of approximately 20-25 employees in the following programs within CCRC at NYU and Bellevue : Electrophysiology, Hypertrophic Cardiomyopathy, Geriatrics, Heart Failure, General Cardiology, and Interventional Cardiology / Cath Lab. Develops and oversees research studies and creates standards and guidelines for clinical research services and programs. Ensures adherence to standard operating procedures (SOPs), good clinical practice and FDA regulations. Oversees the financial and protocol development for studies within the CCRC. Manages the recruitment strategies, enrollment, grant submissions, and study coordination. Works autonomously and with limited oversight.

JOB RESPONSIBILITIES :

• Clinical Research Portfolio Management (40%) Meetings with PIs, sponsors, and other stakeholders NYU Office of Clinical Trials / IRB - If applicable, oversee the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and / or forms to appropriate destination. Ensures the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA and required obligations to patient / subject, Principal Investigator, research team and the sponsor. Monitors any outward effects or issues regarding patient / subject safety and reports this to the appropriate party. May also oversee the monthly enrollment statistics submission to the Office of Clinical Trials, and provides other information in timely manner. Assigns / recommends staffing levels based on protocol needs. Ensures adequate staffing and coverage of projects Reporting and Data Analysis - Prepares progress reports to funding agencies and presentations to sponsoring and regulatory agencies. Prepares and provides reports to all necessary parties (e.g., the principal investigator, sponsoring agency, etc.) on the progress of the study as needed. Recommends changes / additions to established data fields. Analyses data collected, formulates, prepares database and generates a complete measurement report for review by the director. May oversee staff assigned to this responsibility. Study Regulations and Compliance - Aware of study regulatory status and keep an up to date copy of regulatory documents. As needed, assists with the informed consent process and ensures that the patient / subject fully understands what is required of them throughout the study. Monitors any outward effects or issues regarding patient / subject safety and report this to the Principal Investigator, Physician, Physician Assistant and Research Nurse. Reminds patient / subjects of visits and compliance in a consistent manner. Recruitment - Manages the recruitment process for study / program. Screens potential patients / subjects for eligibility to the study. This may include gathering information from the medical record, physician referral, advertisement and directly scheduling a visit to evaluate the patient / subject. Reviews all the elements of the screening process with the Principal Investigator that being : inclusion / exclusion criteria, completed informed consent, documentation of the event and the patient / subject willingness to participate in the study. Responsible for the management, generation, analysis and compiling of study progress reports, financial reports and metrics for a wide audience, including NHLBI, the Steering Committee, DSMB, etc. Develops study SOPs and documenting best practices Oversee and manage the logistics around a new site start-up, including activities such as finalizing customized informed consents, assist and review IRB submissions and respond to queries, reviewing site regulatory documents, negotiating budget terms, etc. Manage and oversee the trial start up activities including development / revision of the final protocol, template informed consent for site use, study manual of operations, CRF guidelines and study training materials Project Manager for Colcorona-NYC study (lead site start-up across the US and local site activities as enrolling site at NYU)
• Financial / Budget Management (10%) Develops and negotiates budgets with study / project leader, and monitors budgets throughout trials. Reviews sponsor-proposed budgets for adequate coverage and recommends changes as appropriate. Preparation of funding reports to funding agencies. May identify new potential sponsors / agents for trials and researches and participate in the development of protocols as assigned. Grants - Oversees the preparation of grant applications and other grants related activities such as developing grants applications / proposals and fund raising activities if applicable. Collects and organizes required paperwork for submission if required for the grant. Follow up and coordinates resolution of all issues progress reports to the sponsors to fund medical research in the division. Other financial management items, including, but not limited to : (i) reconciliation, (ii) contract reviews, (iii) vendor negotiations, (iv) payroll, and (v) projections
• HR / Staff Development (20%) Supervisory - Recruit, hire, train, and supervise research coordinators, project assistants / managers, and volunteers for the program. Ensures all office policies and procedures are being implemented. Holds one-on-one meetings and conducts performance evaluations and corrective action plans. Develops, prepares and revises training / onboarding materials, develops curriculum, and ensures satisfaction through various measurement tools. Administrative- timesheet and attendance adherence review, purchasing equipment, supplies, etc.
• Strategy / Program Development and Operations (30%) Performs quality reviews to ensure compliance and adherence to protocols, IRB, and FDA standards / regulations. Leads ongoing strategic reviews to identify systematic issues and areas for improvement; works with team members to troubleshoot. Lead team meetings and trainings. Assist in the development of strategic planning to ensure proper business development activities with PIs and leadership. Participate, contribute and provide significant input in projects, working groups, and initiatives for the improvement of structures, procedures, policies and guidelines within cardiology and other special projects as needed. Development of SOPs and tools (studies, programs, etc.). Prepares reports and presentations for meetings with PIs and leadership. Project Management - Oversees planning / management of study activities for the whole team and of multiple projects as assigned. Reviews progress of projects and initiate appropriate actions to achieve target objectives. Decision Making and Problem Solving - Combines and evaluates information and data to make decisions about relative importance of information and choosing the best solution to solve problems. Monitor key metrics / KPIs / KCIs to identify and address gaps and deficiencies.

MINIMUM QUALIFICATIONS : To qualify you must have a Bachelor degree or equivalent in business administration, health care administration or related discipline. Minimum of four years of progressively responsible related experience coordinating clinical / research trials studies. Proficiency in using various Microsoft Office applications such as World, Excel, Access, Power Point and Outlook. Familiar with Internet applications. Effective oral, written, communication, interpersonal skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Ability to work and make decisions independently. Time management skills and ability to multi task. Strong understanding and knowledge base of coordination requirements associated with clinical / research trials. Ability to identify, analyze and solve problems; ability to work well under pressure.

PREFERRED QUALIFICATIONS : Clinical Research Coordinator (CRC) Certification is preferred (required in some disciplines). Knowledge of basic medical terminology is preferred.

Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. NYU Grossman School of Medicine is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit for more information. To view the Pay Transparency Notice, please click here.

Required Skills Required Experience