Research Regulatory Associate, Early Drug Development

msk; New York (NY); Hybrid; USD 69,000 - 108,000; Full time

Job summary

Memorial Sloan Kettering Cancer Center in New York City is seeking a Research Regulatory Associate to manage regulatory tasks and documentation for clinical trials across multiple Principal Investigators and study teams.

You will maintain audit-ready regulatory files, ensure protocol and policy compliance, and serve as primary contact for Sponsors/CROs, advancing study progress and overall regulatory compliance within a hybrid work environment.

Qualifications

• 2 years of Clinical Research/Regulatory experience.
• Knowledge of human subject protections and HIPAA regulations.
• Ability to communicate findings clearly across internal and external partners.

Responsibilities

• Manage regulatory tasks and documentation for clinical trials across multiple Principal Investigators.
• Maintain up-to-date regulatory files and ensure protocol/policy compliance.
• Communicate study progress to internal and external partners and identify trends.
• Serve as primary contact for external Sponsors/CROs and participate in protocol meetings.
• Develop and revise protocol tools to ensure accurate conduct of clinical research.

Skills

HIPAA regulations

Attention to detail

Analytical skills

Planning and prioritizing

Excellent communication

Job description

About Us:

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.

Exciting opportunity at MSK: Join our Early Drug Development team as a Research Regulatory Associate !

Role Overview

Manage all regulatory tasks and documentation for clinical trials across multiple Principal Investigators and research study teams. Ensure MSK is always audit-ready by maintaining up-to-date documents, regulatory files, and ensuring protocol and policy compliance. Proactively identify opportunities to contribute to the team's success, bringing innovative ideas and solutions to the table. Effectively communicate the overall study progress to various internal and/or external partners, identify study trends, and build/implement solutions. Take ownership of key tasks while developing new skills and expanding knowledge. Primary point of contact for external Sponsors/CROs and participate and/or lead weekly protocol meetings. Ensure the accurate conduct of clinical research by developing, revising, and maintaining accurate protocol tools at all times.

Key Qualifications

• 2 years of Clinical Research/Regulatory experience.

Core Skills

• Knowledge and understanding of regulations pertaining to human subject protection and the Health Insurance Portability and Accountability Act (HIPAA).
• Outstanding attention to detail and strong analytical skills; capacity to operate autonomously and drive a high volume of work forward.
• Strong planning and prioritizing skills to meet commitments aligned with organizational goals.
• Critical thinking and problem-solving abilities to ensure unforeseen issues are handled appropriately and resolved in a timely fashion.
• Excellent communication skills and the ability to interact across all levels in a confident, professional manner.
• Enthusiasm and dedication to MSK's vision, mission, and values.

Additional Information

• Location: NYC
• Schedule: Hybrid
• Reporting to the Research Project Manager

Helpful Links

Compensation Philosophy Benefits

Pay Range

$69,400.00 - $107,600.00

FSLA Status

Exempt

Closing

At MSK, we believe in fair, competitive pay that reflects your job, experience, and skills.

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.