Associate Director, Research Operations (Monitoring and Regulatory) in New York, NY for Memorial Sloan Kettering Cancer Center (2024)

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Internal Number: 75037

Pay Range

$143,600.00-$237,000.00

Company Overview

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 an Associate Director, Monitoring and Regulatory! We're looking for a dynamic clinical research professional to lead our monitoring and regulatory teams.

Role Overview:

• Lead strategic planning to develop monitoring and regulatory oversight plans and associated team allocations to meet company and study-specific objectives
• Recommend, initiate, and implement operational changes, new services and/or activities.
• Provide appropriate oversight for the PCCTC's clinical research portfolio, adhering to all federal regulatory requirements and International Council for Harmonization guidance on Good Clinical Practice.
• Lead, mentor, and develop the teams to ensure compliance with PCCTC SOPs and study-specific monitoring and TMF plans.
• Review trip reports, expense reports, and invoices related to monitoring activities; contribute to financial planning for the monitoring program.
• Review Trial Master File processes, structure, and completeness for PCCTC portfolio and find opportunities to enhance completeness and currency of regulatory documentation.
• Develop cross-functional processes and relationships to ensure streamlined collaboration across divisions.
• Develop analytical methods to track monitoring results and findings to measure impact and success.
• Support PCCTC regulatory agency submissions (e.g., FDA) through collaboration with cross-functional teams and other collaborators.
• Work with PCCTC leadership to develop and implement continuous quality improvement and inspection readiness initiatives.

Key Qualifications:

• 7+ years of clinical research experience.
• 4+ years monitoring and regulatory experience.

Core Skills:

• An engaging leader with a strong team- building focus.
• Broad-based and detailed knowledge of Human Subjects Protection, Good Clinical Practice, FDA requirements, clinical research-related federal regulations, HIPAA.
• A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation and solve problems.
• Planning and prioritizing work to meet commitments aligned with organizational goals.
• Critical thinking and problem-solving to ensure unforeseen issues are handled appropriately and resolved in a timely fashion.
• Outstanding 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: Remote, with the possibility of occasional travel for monitoring oversight visits or in-person meetings.
• Reporting to the Senior Director, Research Operations

Pay Range: $143,600.00-$237,000.00

Helpful Links:

• 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!

#LI-Remote

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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