Research Regulatory Associate, Leukemia
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.
- 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 2 years of experience working in clinical research, preferably with experience in the regulatory space
- Monday - Friday, 9 AM - 5 PM. 37.5 hours per week.
- There will be some weekend work expectations to cover potential Serious Adverse Events (SAE) reporting.
Application Hiring Process
New York, NY
At MSK, we are committed to providing exceptional patient care that is as convenient as possible. Each of our facilities serves a purpose and is strategically built to support a larger community, including our employees.