Research Regulatory Associate – Multi-Site Compliance (Montvale, NJ)
Job Posting Number: 28028
January 3, 2019
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.
For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.
Our Multi-Site Compliance team is hiring for a Research Regulatory Associate (RRA). As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements the Research Regulatory Associate performs data collection, quality control regulatory oversight tasks for prospective and retrospective research protocols, projects, and databases within Memorial Sloan Kettering Cancer Center. You will be responsible for data/project management activities, for data and regulatory accuracy, and integrity associated with clinical research within the Cellular Therapeutics Center.
This is an exciting opportunity to join a growing clinical research team.
- Review routine and ongoing regulatory documentation including but not limited to, protocol amendments, deviations, serious adverse events, continuing review reports.
- Perform regular audits to ensure that the data collected is complete and accurate and to ensure that the research project is/was carried out as outlined. This may include generating data queries and developing plans for data resolution.
- Create protocol development tools including eligibility checklists, CTMS calendar builds, protocol order sets, CSP coordination, eATO builds, etc
- Perform regular audits of regulatory documentation to ensure files are complete and compliant.
- Work with management, as needed, to assist with protocol development activities including reviewing protocol logistics during the review process.
- Assist in departmental and institutional, internal and external, protocol audits- reviewing and collecting regulatory documents and providing data entry assistance if needed.
- Develop a system for housing, and maintain current versions of, all departmental physician CVs, medical licenses, and certifications.
- Participate in special projects and task forces as determined by management.
- Utilize appropriate methodologies to collect patient/human subject information for a regulatory activity, research project, database, and/or protocol.
- Generate reports to all necessary parties on the progress of the regulatory activity, research project, database, or protocol, as needed.
- Assist in managing departmental data. Communicates with staff at all levels (principal investigators, clinical and research support staff).
- 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. Lead ongoing departmental projects and crafts processes to complete goals.
- Participate or coordinate on both interdepartmental and intra-departmental organization-wide research projects as requested.
- Provide leadership, organizational, creative, or clerical support to established and new research initiatives.
- High School Diploma/GED 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.
- Experience in sponsored and cooperative group clinical research preferred.
- Microsoft applications, database knowledge a plus.
- 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) is essential.
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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