Research Regulatory Associate - Department of Surgery

Company Overview

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.

Job Description

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 are seeking a Research Regulatory Associate (RRA) to join our Department of Surgery. 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 support a variety of services in the department focusing primarily on prospective investigator-initiated studies.

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.
  • 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.

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.
  • Knowledgable 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.
  • A Bachelor’s degree is preferred with 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.

Closing

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.  

 

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

 


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