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NYU Langone Health · 2 days ago

Senior Research Coordinator

New York, NY

Full-time

Onsite

Mid, Senior Level

$71K/yr - $79K/yr

4+ years exp

NYU Langone Health is a leading medical institution committed to improving the human condition through medical education, research, and patient care. They are seeking a Senior Research Coordinator responsible for managing and coordinating research studies, overseeing financial and protocol development, and ensuring compliance with regulatory standards.

EducationHealth CareHospitalMedicalNon Profit

Growth Opportunities

Responsibilities

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

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

Might oversee the monthly enrollment statistics submission to the Office of Clinical Trials, and provides other information in timely manner, as necessary

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

Aware of study regulatory status and keep an up to date copy of regulatory documents

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 and Research Nurse

Reminds patient/subjects of visits and compliance in a consistent manner

Oversees planning/management of study activities and of multiple projects as assigned

Reviews progress of projects and initiate appropriate actions to achieve target objectives

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

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

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 supervisor

Provides guidance, training, leadership to less experienced staff

May have input into staff evaluations

Participates in special projects and performs other duties as required

Qualification

Clinical Research CoordinationBudget ManagementData AnalysisMicrosoft Office ProficiencyProblem SolvingMedical Terminology KnowledgeEffective CommunicationTime ManagementTeam CollaborationLeadership