Regulatory Associate, PCCTC
- Memorial Sloan Kettering Cancer Center
- Remote
- About 1 month ago
Job Description
Pay Range: $66,500.00-$103,100.00 Company Overview:
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Role Overview:
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The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.
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Job Description: Exciting opportunity at MSK: Join our team as a Regulatory Associate, Prostate Cancer Clinical Trial Consortium! We’re looking for a dynamic clinical research professional to provide support to our Regulatory PCCTC team.
Role Overview:
- Partner with Project Associates, Monitors and other study personnel to maintain comprehensive, GCP/FDA compliant, regulatory files for protocols.
- Perform regular audits to ensure that regulatory documentation is complete, up-to-date, and accurate, and that site qualifications are maintained throughout the duration of a study.
- Prepare for internal and external audits of a protocol (e.g. conduct pre-audit review of the regulatory files).
- Perform a complete Quality Assurance review of all regulatory documents in line with plans to close sites and/or studies.
- Manage and audit the PCCTC electronic TMF system, including system user management and system functionality assessment, implementation, and oversight. Support program-level TMF structure development and management and study-specific TMF setup.
- Support and/or deliver training on policies and procedures relative to the TMF system.
- Complete all required certifications per company requirements (e.g., Human Subjects Protection, HIPAA), and ensure research team compliance of such trainings for all involved in the clinical trial.
Key Qualifications:
- 2-7 years of Clinical Research/Regulatory experience.
- Oncology clinical trial experience, global trial experience a plus
Core Skills:
- Knowledge 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).
- Familiarity with a variety of TMF systems and the regulatory requirements around electronic TMFs.
- Excellent organizational, prioritization, and project management skills.
- Dedicated to accuracy with high attention to detail.
- Outstanding communication skills and ability to resolve how to best reach different audiences.
- Ability to solve problems by using a logical, systematic, sequential approach.
Additional Information:
- Location: Remote
- Reporting to the Regulatory Manager, PCCTC
Pay Range: $66,500 - $103,100
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- MSK Compensation Philosophy
- Review our great benefits offerings
Learn more about PCCTC: The Prostate Cancer Clinical Trials Consortium (PCCTC) was initiated in 2005 by the Prostate Cancer Foundation (PCF) and the U.S. Department of Defense (DOD) Prostate Cancer Research Program (PCRP) in response to critically unmet needs in prostate cancer clinical research identified by physician investigators and patient advocates. To fulfill our mission, we developed a unique infrastructure which has fostered a culture of transparent project co-development between investigators, research sites and industry partners. Established as an independent entity in 2014, the PCCTC, LLC is now the nation’s premier multicenter clinical research organization specializing in ground breaking prostate cancer research.
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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.
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