Hospital For Special Surgery New York , NY 10007
Performs data collection and data entry for studies as requested. Schedules and conducts subject interviews, follow-up visits and phone calls to obtain data as per protocol. Ensures accuracy when transcribing data from data collection sheets, medical records, or electronic institutional databases or other source documents into databases.
Performs or helps facilitate informed consent procedures following all regulatory guidelines.
Develops and maintains research databases with guidance from Principal Investigator and/or statistician.
Participates in research leadership initiatives and committees. Proactively suggests improvements.
Participates in protocol development in collaboration with Principal Investigator and co-investigators. Conducts literature searches; actively participates in development meetings; reviews and edits protocol document; prepares study initiation documents.
Prepares initial drafts of protocols and manuscripts as requested by the Principal Investigator or Assistant Director, Research.
Performs IRB submissions for initial approvals, re-approvals, amendments, etc. Prepares, submits and files IRB and all regulatory documents, ie., data collection sheets, protocol amendments, protocol deviations, adverse event forms, etc.
Prepares information required for reports to research administration as needed.
Ensures that all research related regulatory, institutional, and departmental compliance requirements are met as appropriate.
Conducts statistical data analysis and prepares statistical graphs and tables in preparation for research presentations, abstract and manuscript preparation or for other publications as requested by the Principal Investigator.
Provides timely progress reports (especially regarding enrollment) for each research project at regular intervals determined by the Assistant Director, Research or Principal Investigator.
Prepares and maintains orderly files for all research studies, including both electronic and hard copy paper files in regulatory binders. Works closely with HSS internal monitor for guidance on these activities.
Assists Attending MDs with academic tasks, such as preparing PowerPoint slides and conducting literature searches for presentations as requested.
Responsible for the handling, packaging, and shipping of dangerous goods under supervision and in compliance with State and Federal regulations. These specimens may include tissue, blood, dry ice, and chemicals. Certification in these procedures is required in accordance with Federal Regulations. Knowledge of good clinical practice for the handling of specimens and blood may be required.
Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in research and the field of anesthesiology.
Bachelor's degree required, master's degree preferred
Minimum 3 years of full-time clinical research experience
Proficient use of computers and software, including Microsoft Excel and Word
Experience with electronic data management, statistical, and citation management programs preferred
Experience with FDA submissions and/or industry-sponsored research preferred
Research certification (CCRC, CCRP) preferred