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Position Summary:

We have an exciting opportunity to join our team as a Sr Cardiology Research Manager.

The successful candidate will oversee and provide daily management of Clinical Research Teams consisting of 1 or more Program Managers, multiple research coordinators, and other clinical research staff members.

The Sr. Cardiology Research Manager (RM) in collaboration with the clinical investigator(s) will be responsible for the planning, implementation, and execution of clinical trials. The RM will be responsible for managing the coordination of study enrollment, maintaining subject databases, protocol treatment and follow-up care for subjects participating in clinical trials. The RM will assure that the clinical trial study protocols are followed by all study staff. The RM will work closely with the study sponsors from qualification visit to close out visit. The RM will manage and oversee reporting of SAEs to the IRB and Sponsors. The RM will guarantee submission of all required research related activities to the IRB and that clinical trials are conducted in adherence with FDA, IRB, New York, and related regulations. The RM will make certain that research protocols are accurately executed in accordance with Good Clinical Practices, HIPAA and required obligations to patient/subject, Principal Investigator, clinical research team and the sponsor. The RM may interface directly with patients/subjects in support of the clinical trials if applicable. The RM will work independently to drive the day to day activities surrounding the clinical trial conduct. The RM will oversee multiple active protocols and work with multiple investigators. In addition, the RM will plan study budgets and oversee the financial management of clinical research studies. The RM will be the liaison with the Department of Medicine research administration and other NYU offices such as IRB and the Office of Science and Research.

This position will report jointly to the Department of Medicine Program Director for Research and the Administrator for the Division of Cardiology.

Job Responsibilities:

• Demonstrates knowledge of the organizations Core Values and incorporates them into the performance of duties.
• Supervisory – Recruit, hire, train, complete employee performance reviews, supervise a team of research coordinators, and 1 or more program managers
• Financial Develops draft budget, monitors budget throughout trial and recommends staffing levels based on reviewed protocol. Reviews sponsor-proposed budget for adequate coverage and recommends changes as appropriate. Develops draft and final budgets together with study/project leader. Preparation of funding reports to funding agencies. Might identify new potential sponsors/agents for trials and researches and participate in the development of protocols as assigned.
• NYU Office of Science and Research/IRB & Central IRBs Oversees the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Science and Research, and Central IRBs (when applicable) 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. Oversees the monthly enrollment statistics submission, reports information as necessary.
• 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; Program Director, Research 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 investigators.
• Data Management Oversees data collection of subject/patient information for the research project(s). This may include abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, surgical/radiation treatments delivered, adverse drug reactions, etc.); abstraction of data for publications, or data collection from outside physicians offices. Audits and manages data from and into the database. Prepares forms and reports, compiles and analyses data, statistics, and other materials for reports.
• Human Subjects Regulations Ensures study management and regulatory compliance with the clinical research process. Responsible for the QA aspects of clinical trials of Cardiology. Ensures that clinical research personnel are trained and understand their responsibilities with respect to the Clinical Research Management System (CRMS), Good Clinical Practice (GCP), IRB, Federal, and State and Institutional regulations.
• 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.
• Grants – Assists with 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 coordinate resolution of all issues progress reports to the sponsors to fund medical research in the division.
• 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. Resolves complex situations based on established policies and procedures and refers non solved issues and questions to the Principal Investigator and/or Program Director, Research as needed.
• Continuous Learning Position requires ongoing continuing education in all areas of research development. Promotes own professional growth and development in role and maintain current expertise in area of practice. Serves as a resource to the clinical research team and works collaboratively with other disciplines within the area of expertise.
• Works autonomously and with limited oversight.
• Participates in special projects and performs other duties as required.