Regulatory Research Associate - Epidemiology & Biostatistics

---

Job description

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. 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.

Job Description:
As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, the RRA performs 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.

You will:

Work closely with the Operations and Compliance departments to ensure all activation-specific aspects of regulatory oversight are carried out for trials in the Protocol Activation Core.

Assist in development of protocol tools required for trial activation

Communicate with staff at all levels (principal investigators, clinical and research support staff), Clinical Research Organizations, and study Sponsors

Ensure that workflow is controlled and meets departmental needs.

Manages ongoing departmental projects and crafts processes to ensure that goals are met.

Participate in special projects and task forces as determined by management.

Generate reports to all necessary parties on the progress of the protocol, as needed.

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.

Bachelor's degree is preferred.

At least 1 year of experience working in clinical research, preferably with experience in the regulatory space, is required.

#LI-POST

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.