Regulatory Research Project Manager, Early Drug Development

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 pursueour missionat MSK and around the globe.

Exciting opportunity at MSK: Join our team as a Regulatory Research Project Manager, Early Drug Development! We're looking for a dynamic clinical research professional to lead a team of regulatory associates team focused on regulatory and study start-up activities for Early Drug Development research studies.

Role Overview:

Supervise the day-to-day activities of Research Regulatory Associates (RRAs) to ensure efficient and effective operations.
• Manage a quality assurance program by reviewing research for accuracy and compliance.
• Support the work of attendings, fellows and research staff to accomplish research goals, with a focus on their pre PAC work and related projects.
• Liaison/point of contact between PI and collaborator/sponsor during pre PAC phase.
• Assist with preparing and submitting new studies to the Protocol Activation Core (PAC) and ensure all the necessary study tools are completed prior to study activation.
• Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a project and/or database.
• Perform quality checks of protocol regulatory binders to confirm all item are in regulatory compliance.
• Prepare waivers and data use agreements (as needed) for service research projects.
• As needed, ensure that Serious Adverse Events (SAEs) are completed and reported to the SAE Manager in the IRB/PB, Office of Clinical Research and, if necessary, the sponsor.
• Ensure proper submission of single patient use trials and exception letters to the IRB/PB.
• Oversee audit and inspection readiness tasks performed by direct reports and other members of the team.

Key Qualifications:

• At least 3.5 years of regulatory experience in clinical research and supervisory/project management.
• Extensive knowledge and understanding 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 computer systems, databases, data analysis and data reporting is essential.
• EPIC knowledge is a plus.

Core Skills:

• Attention to detail, strong time management/project management skills.
• Confidence navigating and steering new and unique project proposals.
• Focus on continuous improvement, knowing the most effective and efficient processes to optimize workflows.
• Eagerness to foster talent and support people in meeting their career goals and the organization's goals.
• Exceptionally organized and demonstrated consistent success under pressure.
• Ability to solve problems by using a logical, detailed, sequential approach.
• Excellent interpersonal, verbal, and written communication skills.
• Strong organizational, prioritization, and project management skills.
• Enthusiasm and dedication to MSK's vision, mission and values.

Additional Information:

• Location: BAIC, 300 E 66^th Street, NYC
• Schedule: Hybrid
• Reporting to the Clinical Research Manager

Pay Range: $90,700.00-$145,300.00

Helpful Links:

• MSK Compensation Philosophy
• Review our great benefits offerings

Learn more about clinical research at MSK: Research is integral to our mission at MSK and clinical trials help us discover better forms of patient care and treatment. Our outstanding scientists and clinicians work together to drive innovation and tackle some of the greatest challenges of biomedical science!

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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