Regulatory Research Project Coordinator – GUP (Genitourinary Prostate) Service, Department of Medicine
Job Posting Number: 20232
New York, NY
June 22, 2018
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
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The GUP (Genitourinary Prostate) Service within the Department of Medicine is hiring 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 regulatory tasks and quality control for research projects, databases, and research protocols within Memorial Sloan Kettering Cancer Center. Responsible for project management activities and regulatory document integrity associated with clinical research within the disease management team and/or service specific level. Participates in special projects and task forces as determined by management.
- Work closely with management to assist with protocols in development. Develop protocol tools such as eligibility checklists, order sets, patient diaries, and databases.
- Be responsible for regulatory document collection, tracking, filing and submission to the IRB and industry partners.
- Schedule and host site initiation visits for new protocols.
- Maintain central storage of all delegation logs, CVs, medical licenses, certifications and ensure they are current.
- Participate in special projects and task forces as determined by management.
- Utilize appropriate methodologies to complete regulatory reports and protocol amendments. Ensure proper staff are trained at appropriate intervals.
- Generate reports to all necessary parties on the progress of the research project, database, or protocol, as needed.
- Communicate with staff at all levels (principal investigators, clinical and research support staff) and serve as a liaison between industry partners, CROs and site staff.
- Perform regular audits of regulatory binders to ensure documentation is complete and accurate, and to ensure that research project was carried out as outlined. Collaborate with study staff to reconcile any deficiencies in documentation.
- 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 workflows are controlled and meets departmental needs. Manage ongoing departmental projects and creates processes to ensure that goals are met.
- Participate or coordinates on both interdepartmental and intradepartmental organization-wide research projects as requested.
- Provide leadership, organizational, creative, or clerical support to established and new research initiatives. Conduct regulatory training for Research Study Assistants.
- 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 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.
- 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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