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Position Summary:
We have an exciting opportunity to join our team as a Research Coordinator.
Responsible for providing moderate to advanced range of coordination of research studies conducted within the Division of Cardiologys Cardiac Cath Lab. Coordinator will assist with the recruitment, enrollment, research data collection and study coordination activities. Performs intra-operative monitoring and serves as liaison with internal and external funding agencies. 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 sponsor. Interfaces directly with patients/subjects, Principal Investigator, Program Manager, and Assistant Director of Research in support of the clinical trials. Establishes liaisons with relevant parties at the Medical Center that may include: Research Nurses, Research Pharmacists, Program Managers, Medical Technicians, Clinical Information Systems and regulatory Services. Might assist in the initiation and management of research studies.
Job Responsibilities:
• Human Subjects' Research - As applicable, prepares and completes the submission of necessary documents required by the NYU Institutional Board (IRB), NYU Office of Clinical Trials, Bellevue Hospitals Research Committee, and any other appropriate parties in order to obtain approval to conduct human subjects research (e.g., ensures the update and submission of necessary documents and/or forms to appropriate destination). Might prepare, audit and submit monthly enrollment statistics to the Office of Clinical Trials, and provides other information in timely manner, as necessary.
• Study Regulations - Aware of study regulatory status and keep an up to date copy of regulatory documents. Conducts the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Follows through regularly with the patient/subjects reminding them of visits and compliance. May monitor any outward effects or issues regarding patient/subject safety and report this to the Principal Investigator, clinician, and manager.
• Data Management - Responsible for collecting and auditing 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. Conducts study visits, obtains and documents information within the time frame specified.
• Budget Assists with development of a preliminary draft budget and submit to the PM/Asst. Director/Principal Investigator. Reviews sponsor-proposed budget for adequate coverage of PI and coordinator time and effort and recommend changes as appropriate. Assists in the preparation of funding reports to funding agencies and helps identify new potential sponsors/agents for trials and researches. Monitor budget throughout trial.
• 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 and refers non resolved issues and questions with recommendation to supervisor.
• Participates in special projects and performs other duties as required.
• Recruitment - 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.
• Compe
Location: Brooklyn, NY
Posted: Nov. 19, 2024, 4:04 a.m.
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