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 are seeking a Research Regulatory Associate (RRA) to join our Multiple Myeloma service within the Department of Medicine. In this role, you will ensure the proper conduct of clinical research by developing, revising and maintaining accurate protocol tools at all times.

You will:

• 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.
• 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.

You Are:

• 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).

You Have:

• 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

Note:

• There will be some weekend work expectations to cover potential Serious Adverse Events (SAE) reporting.