Research Regulatory Associate – Immunotherapeutics Core Service, Department of Medicine
Job Posting Number: 25456
New York, NY
September 14, 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.
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.
Are you passionate about clinical research? Do you want to join a growing team?
We have a Research Regulatory Associate (RRA) opportunity in our Immunotherapeutics Core Service for the Department of Medicine.
As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, the RRA performs all tasks associated with the regulatory management of research protocols within MSKCC. The RRA will be responsible for ensuring MSK is audit ready by maintaining up-to-date regulatory documents and regulatory files. The RRA also ensures the proper conduct of clinical research by developing, revising and maintaining accurate protocol tools at all times.
- Utilize appropriate methodologies to ensure the regulatory documents and tools for protocols are accurate, up-to-date, comprehensive and well organized.
- Design accurate and complete protocol tools, including but not limited to patient/human subject calendars, eligibility checklists, protocol order sets, PK sheets, schedules and training logs to facilitate data collection required for the conduct of a study. Ensure all necessary training documents are prepared and ready.
- Work closely with Protocol Activation Core to successfully manage all protocol regulatory activities required for study activation.
- Maintain comprehensive, GCP/FDA compliant, regulatory files/binders for protocols. This includes, but is not limited to, collection and maintenance of the FDA Form 1572, Financial Disclosure Forms, Delegation of Authority logs, training logs, laboratory reference ranges and CLIA documentation, CVs and Licenses, Investigator Brochures, and Safety reports.
- Use research databases to manage regulatory aspects of trials. Attend necessary trainings to ensure system understanding.
- Ensure PI and participating investigators/consenting professionals and research staff are trained on protocol and protocol amendments and maintains up-to-date training logs.
- Prepare and submits all documents needed for protocol amendment, including the informed consent form to the IRB and update all protocol tools accordingly in real time with IRB amendment submission.
- Provide support to the PI for the preparation and submission of single-patient use protocols to the IRB, external sponsor and federal agencies.
- As directed by Manager, attend departmental research meetings or service trainings as needed.
- Develop reports in collaboration with the Clinical Research Coordinator (e.g. Continuing Review Reports, Data and Safety Monitoring reports, toxicity/adverse event documentation,) and perform advanced queries for Principal Investigator (PI), disease management team, sponsoring agency, Institutional Review Board/Privacy Board (IRB/PB), etc., as needed. Provide support to the PI in the creation of IND application, and IND annual reports.
- Draft Protocol/Study Note to File and memos, review and obtains approval from Principal Investigator, and submit to MSK IRB and/or sponsor as needed.
- Ensure that Serious Adverse Events (SAEs) are completed and reported to the SAE Office in the IRB/PB, and the sponsor if applicable, as per institutional and protocol requirements.
- Respond to regulatory issues noted on monitoring letters from sponsor.
- Perform regular audits at the time of continuing review to ensure that the regulatory documentation is complete, up-to-date, and accurate and to ensure that the research protocol is in compliance with regulatory agencies.
- Verify that all participants are consented/re-consented and appropriate documentation is available in the EMR per institutional/external sponsor/federal guidelines. Conduct routine quality checks on consent documents and process.
- Prepare for internal and external audits of a protocol (e.g. conducts pre-audit review of the regulatory files).
- Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the conduct of a clinical trial.
- Complete all required certifications per institutional requirements (e.g., Human Subjects Protection, HIPAA), and ensure research team compliance of such trainings for all involved in the clinical trial.
- Access, use and disclose protected health information per institutional, state and federal requirements.
- A minimum of a High School Diploma with experience in clinical research or applicable experience.
- A Bachelor’s degree is preferred.
- At least 2 years of relevant clinical research experience 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
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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