Vacancy expired!
Req Number 58330Job DescriptionJob DescriptionServes as a Regulatory Research Coordinator for the Northwell Health Cancer Institute maintaining a master regulatory file, both on paper and electronically for each clinical research study. Liaisons with the IRB to submit amendments, prepared consent forms, study progress reports, ongoing correspondence regarding the study status, Data Safety Monitoring information and participates in the preparation of regulatory documents for audits.Exhibits technical and functional expertise in the area of research through the development of protocols, hypotheses and educational curricula. Coordinates daily activities of a designated study or group of studies and maintains industry relationships. Guides training of faculty physicians, residents, medical students and research staff on good clinical practice, external regulatory agency requirements.Job ResponsibilityDevelops scientific protocols and generates hypotheses for research inquiries independently and in collaboration with faculty and trainees; provides technical and functional expertise in the area of research studies.
Creates and implements research education core curriculum for residents and faculty in conjunction with physician leadership; coordinates visiting professors for research topics; prepares lectures and presentations on research topics.
Drafts research policies with departmental leadership - participates on departmental research board to vet proposed projects for feasibility, ethics and academic rigor; prepares manuscripts for publication in peer-reviewed journals and scientific meetings.
Uses statistical software to analyze study data and interface with biostatisticians for analysis; engages physician leaders from various specialties to develop collaborative multidisciplinary research.
Oversees the administration of assessments as assigned and as related to study protocol.
Collects data, confers with PI and forwards results to sponsor (internal or external).
Interfaces with external agencies; organizes all phases of grant process for submission to funding agencies as necessary.
Oversees clinical research staff performing clinical functions i.e. phlebotomy, monitoring vital signs on study participants, etc., when warranted; educates family and contributes to the care and evaluation of subjects, including determining preliminary inclusion/ exclusion criteria.
Liaises with agencies, pharmaceutical companies, laboratories, and equipment and supply companies as needed; oversees availability of supplies and/or equipment for studies.
Identifies and pursues extramural funding opportunities through pursuit of grants and clinical trials; collaborates with physicians, investigators and other healthcare providers regarding subject care as necessary.
Operates under limited guidance and work assignments involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.
Job QualificationBachelor's Degree required, or equivalent combination of education and related experience.
3-5 years of relevant experience, required.
Vacancy expired!