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Memorial Sloan Kettering Cancer Center is seeking a Research Project Coordinator for the Immunotherapeutics Core (ITC) in the Department of Medicine. As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, this person will perform data collection, quality control and data analysis for research projects, databases, and research protocols within MSKCC.
You will: * Work closely with the RPM to establish standardized regulatory processes for the team. * Work closely with the CRM to assist in protocols in development (complete all protocol start up documents- ECL, POS, FDFs, 1572, etc). * Supervise Regulatory RSAs. * Oversee the transition of specific regulatory tasks from study teams to regulatory RSAs. * Review deviations and help study teams establish strong CAPAs. * Provide regulatory (re)training/in-services to the team. * Provide regulatory guidance/policy clarifications to the team. * Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. * Assist in protocol audits- review and collect regulatory documents, provide data entry assistance if needed, house all CVs, medical licenses, certifications and ensure they are current. * Liaise with other groups/non-ITC staff who participate in ITC protocols to ensure that their regulatory processes and documentations are adequate. * Identify areas for improvement of regulatory documentation. * Participate in special projects and task forces as determined by management. * Generate reports to all necessary parties on the progress of the research project, database, or protocol, as needed. * Assist in managing departmental data. * Communicate with staff at all levels (principal investigators, clinical and research support staff). * Perform regular in-depth audits of the regulatory binder to ensure that the documents collected are complete and accurate and to ensure that the research project was carried out as outlined. * Ensure that workflow is controlled and meets departmental needs. * Manage ongoing departmental projects and create processes to ensure that goals are met. * Participate or coordinate on both interdepartmental and intradepartmental organization-wide research projects as requested. * Provide leadership, organizational, creative, or clerical support to established and new research initiatives. * Assist in protocol submission, drafting of consents, reviewing protocol logistics. * Utilize appropriate methodologies to collect patient/human subject information for a research project, database, and/or protocol.
You need: * At least 3 years of relevant (clinical research) experience (2 year with Masters), or as determined by hiring manager. * Or a minimum of a High School Diploma with at least 3 – 4 years MSKCC clinical research experience. * A Masters degree is preferred. * Must be able to work independently, be flexible, and meet tight deadlines. * Experience in clinical research and/or other applicable research investigation. Relevant graduate work would be considered in lieu of minimum experience. * Experience coordinating industrial studies. * Microsoft applications, including Access, database knowledge a plus. * A comprehensive knowledge and understanding of the regulations and guidelines pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations), Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Research Guidelines (GCP) and MSKCC policies and regulations.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
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As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, a...nd superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.