Associate Director, Research Operations (Monitoring and Regulatory)

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

The Prostate Cancer Clinical Trials Consortium (PCCTC) is the nation’s premier multicenter Clinical Research Organization specializing in ground breaking prostate cancer research. We work together with distinguished investigators on a single mission: to design, implement and complete studies in prostate cancer, translating scientific discoveries to improved standards of care. We are currently hiring an Associate Director to join our dynamic clinical research team to oversee the Monitoring and Regulatory teams. Join us today and help make a difference every day!

 

You Will:

• 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.

You Are:

• Able to plan, prioritize, facilitate and lead meetings, to develop programs, to manage research projects and to prioritize work across a portfolio of projects.
• An effective communicator, capable of resolving how best to reach different audiences.
• Adept in setting priorities, meeting established deadlines, and leading multiple large scale projects simultaneously.

You Have:

• 7+ years of clinical research experience.
• 4+ years monitoring and regulatory experience.
• Broad-based and detailed knowledge of Human Subjects Protection, Good Clinical Practice, FDA requirements, clinical research-related federal regulations, HIPAA.
• Outstanding communication and presentation skills, both oral and written.
• A strong ability and understanding on how to collect, analyze, interpret and prepare data for presentation and solve problems.

This is a full-time remote position with the possibility of occasional travel for monitoring oversight visits or in-person meetings.

#LI-Remote

Are you ready to learn more about our Benefits?

 

Pay Range $143,600.00-$237,000.00

 

Please click to find out more about MSK’s compensation philosophy!

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 rega