At MSK, were 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 in our Genitourinary(GU) Prostate Service for 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 all regulatory related IRB submissions for the lifetime of a protocol (continuing review reports, amendments, etc).
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.
Proven success in tasks that require attention to detail.
A strong communicator, understanding the importance of providing stakeholders with relevant updates including notification of completed action items.
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 Bachelors degree is preferred.
At least 1 year of experience working in clinical research, preferably with experience in the regulatory space
Monday - Friday, 9 AM - 5 PM
There will be some weekend work expectations to cover potential Serious Adverse Events (SAE) reporting.
Internal Number: 2021-50697
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.