Regulatory Research Project Coordinator – Thoracic Medicine Service, Department of Medicine
Job Posting Number: 23893
New York, NY
August 15, 2018
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The Thoracic Medicine Service within the Department of Medicine is hiring for a Regulatory Research Project Coordinator (RPC). As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements the Research Project Coordinator performs data collection, quality control and data analysis for research projects, databases, and research protocols within Memorial Sloan Kettering Cancer Center. Responsible for data/project management activities and for data accuracy and integrity associated with clinical research within the Thoracic Medicine Service management team. Participates in special projects and task forces as determined by management.
- 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.
- Will be working closely with management to assist in all aspects of regulatory oversight for trials in the service, from start-up through study closeout. This includes, but is not limited to, completion of feasibility surveys, obtaining Regulatory documents from investigators and corresponding with external stakeholders on protocols in development.
- Will assist in protocol submission, revising 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.
- Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project, database, or protocol. Ensures 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.
- At least 3 years of relevant (clinical research) experience (2 year with Masters), or as determined by hiring manager.
- A minimum of a High School Diploma with at least 3 – 4 years MSKCC clinical research experience.
- A Master’s 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.
- 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).
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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