Attention all new applicants
Beginning February 21, 2022, MSK will require all new hires, volunteers, and vendors who come onsite to provide proof of complete COVID-19 vaccination series + booster (once eligible) based on the vaccines' high level of protection and our shared responsibility in protecting our patients. Read more
Regulatory Research Associate
LocationNew York, NY
DeptResearch - Clinical
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. We’re treating cancer, one patient at a time. Join us and make a difference every day.
MSK requires all new hires, volunteers, and vendors who come onsite to provide proof of COVID-19 vaccination. This is based on the COVID-19 vaccines’ high level of protection and our shared responsibility in protecting our patients.
Beginning on February 21, 2022, MSK will require all new hires, volunteers, and vendors who come onsite to provide proof of complete COVID-19 vaccination series + booster (once eligible). Individuals currently eligible for a COVID-19 booster must get their booster, or have an approved exemption as a condition of employment at MSK. Individuals can get their COVID-19 booster 5 months after receiving their second dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine, or 2 months after the Johnson & Johnson vaccine. Individuals who are not yet eligible for a booster must meet this criteria within 30 days of becoming eligible.
At MSK, we’re running one of the largest clinical trials programs for cancer in the country, and at any time we are conducting hundreds of clinical trials to improve cancer care. We have a Research Regulatory Associate (RRA) opportunity with our Solid Tumor Breast Service in the Department of Medicine. As an integral member of the research team, you will perform all tasks associated with the regulatory management of research protocols within MSKCC. The RRA will be responsible for ensuring MSK is audit ready at all times 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.
- Work closely with management to assist in all aspects of regulatory oversight for trials in the service, from start-up through study closeout, and protocols in development.
- Assist in protocol submission, drafting of consents, reviewing protocol logistics.
- Assist in audits- reviewing and collecting regulatory documents.
- 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 handling departmental data. Communicate with staff at all levels (principal investigators, clinical and research support staff).
- Ensure that all appropriate 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 crafts processes to ensure that goals are met.
- 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.
- A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
- Able to hold yourself and others accountable in order to achieve goals and live up to commitments.
- Flexible in your approach and demeanor in order to align with the shifting demands of evolving circumstances.
- Knowledgeable 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).
- A minimum of a High School Diploma with experience in clinical research or applicable experience.
- A Bachelor’s degree is preferred.
- At least 1 year of experience working in clinical research, preferably with experience in the regulatory space
- There will be some weekend work expectations to cover potential Serious Adverse Events (SAE) reporting.
Application Hiring Process
New York, NY
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