[NYUSOM] [NYULMC_P] POSITION DESCRIPTION DEPARTMENT: Breast Surgery- Surgical Oncology JOB TITLE: Research Data Manager GENERAL SUMMARY: Provides data management support for clinical research protocols related to the Breast Cancer Database and High Risk Breast Cancer Consortium. PRINCIPAL DUTIES AND RESPONSIBILITIES: Incumbent may carry out some or all of the following duties: i DATABASE METHODOLOGY: Utilizes the necessary tools to ensure protocol compliance to conduct direct data research. Ø Utilizes established methodologies to collect patient information for the research project(s). Ø Extracts data for publications, or provides data collection from outside physicians' offices. Ø Formats and uses tools to facilitate data collection (e.g., calendars, schedules, tracking logs, etc). Ø Ensures protocol compliance, that is, that standard steps regarding eligibility criteria, follow-up, and required documentation is consistently followed in the time frame specified. Ø Compiles data and assists in consolidating and analyzing data for sponsoring and regulatory agencies. Ø Is responsible to ensure that data collection is correct and consistent with the source document and completed in a timely and organized manner. Ø Completes paperwork and forms in a neat, accurate, timely manner. Ø Maintains files of all required on-going documentation and forms. Ø Assists in preparation for bio-statistical analyses and required reporting. Ø Ensures that information in computer database is accurate, entered and maintained on a timely basis. ii CLINICAL RESEARCH DUTIES Ø Thorough knowledge of research study, study rationale, study subject, and clinical procedures associated with the study. Ø Review all the elements of the screening process with the Research Director (RD). Ø Collaborate with various personnel that may be involved in assisting with specific aspects in the study. Ø Have thorough knowledge of policies and procedures of the host institution where the study is being conducted and the regulatory requirements such as IRB and other approvals if necessary. Ø Works with the principal investigators and research staff on monitoring the overall conduct of the study. Ø Works with the research staff in reporting adverse events to the appropriate regulatory bodies as instructed. Ø Tracks clinical milestones and patient accruals to help evaluate the progress of studies. iii INTERACTS WITH MEDICAL STAFF, and SITE MONITORS: Coordinates, Facilitates and Communicates with Staff and Non-Staff to Produce Required Results. Ø Works with RD and research staff as part of a team. Ø Demonstrates knowledge of and follows proper clinical study processes within current policies and procedures. Ø Recognizes identifies, and moves issues forward as appropriate. Ø Utilizes available resources and established procedures in order to rectify problems, communicates all changes. Ø Liaisons with monitors during site visits, providing them with assistance specific to the monitoring visit. iv COORDINATION OF MATERIALS AND VARIED STUDY ITEMS: Ø Coordinates the shipment and transfer of varied types of materials among the various departments and labs. Ø Works with departments, labs, other personnel and areas as needed, to ensure the timely transfer of items and biological materials: study drugs; histology slides; serum, urine, blood samples, etc., using appropriate precautions at all times. Ø Attends appropriate trainings in the proper handling and collection of biological substances and the packaging and shipment of samples as well as required IRB and HIPAA tutorial. V ADMINISTRATION, ANALYSIS, REPORTING, and Filing: Ø Coordinate IRB approved subject study reimbursements according to standard operating procedures. Ø Maintain complete, accurate subject charts, case report forms, enrollment logs, and hospital records Ø Maintain files in an organized and up-to-date manner in order to facilitate their retrieval and maintains copies of all required on-going documentation and forms for the files. MINIMAL HIRING QUALIFICATIONS: ¨ Master's Degree plus three years related experience or equivalent combination of education and experience. ¨ Statistical skills, including SAS and SPSS ¨ Computer skills, preferably experienced with oracle-based data systems (eVelos), EPIC, etc. ¨ Proven communication skills, ability to work independently within a multidisciplinary environment. ******************************************************************************************* CLICK HERE TO SUBMIT YOUR COVER LETTER AND RESUME.<https://ww3.hunter.cuny.edu/prehealth/view.php?id=72942>