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Memorial Sloan Kettering Cancer Center is seeking a Research Regulatory Associate for the Pediatrics Department. 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.
• Will be working closely with the Clinical Research Manager(CRM) to assist in protocols in development (complete all protocol start up documents- ECL, POS, FDFs, 1572, etc).
• Will assist in protocol submission, drafting of consents, reviewing protocol logistics.
• Assist in protocol audits- reviewing and collecting regulatory documents, provide data entry assistance if needed House all CVs, medical licenses, certifications and ensure they are current.
• Participate in special projects and task forces as determined by management.
• Utilize appropriate methodologies to collect patient/human subject information for a research project, database, and/or protocol.
• 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 audits to ensure that the data collected is complete and accurate and to ensure that the research project was carried out as outlined.
• Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol.
• Ensure that research protocols are approved by the Institutional Review Board and followed as written.
• Ensure that workflow is controlled and meets departmental needs. Manages ongoing departmental projects and creates 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.
• A minimum of a High School Diploma with experience in clinical research or applicable experience.
• A Bachelor’s degree is preferred.
• Must be able to work independently, be flexible, and meet tight deadlines.
• Microsoft applications, database knowledge a plus.
• Must have a comprehensive knowledge and understanding of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
• Monday - Friday, 9 am - 5 pm
*Please note that this position could be based at MSK Bergen in Montvale, NJ or Manhattan depending on where the candidate selected is based.
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.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.