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POSITION SUMMARY: We have an exciting opportunity to join our team as a Research Project Manager. The Project Manager is responsible for proving a broad range of complex program management in conjunction with the Principal Investigators from Radiology & Cardiology and Program Director, in all aspects of the functions of the clinical coordinating center of NIH funded large-scale national clinical trial investigating submassive pulmonary embolism (PE), a disease that often causes cardiopulmonary disability, reduced functional capacity, and decreased quality of life. Catheter-directed therapy (CDT) has the potential to prevent these long-term complications. This study will determine if CDT in addition to anticoagulant therapy, rather than anticoagulant therapy alone, should be used to treat patients with submassive PE.

JOB RESPONSIBILITIES:

The Research Project Manager will report for daily duties to Stephanie Mavromichalis, Program Director in Cardiology and is responsible for the development, promotion, direction and coordination of the trial(s), including research design, budget, staffing, logistics and other supportive functions for the assigned trial sites. Facilitates and has overall responsibility for the administration of assigned trial activities (staff on boarding process, following up with study sites, assisting in the submission of IRB/national regulatory documents, developing budgets, scheduling meetings, planning, organizing and coordinating events, training others etc). Works autonomously with limited oversight. This position reports to the Program Director of the clinical coordinating center and the PI.

Duties include, but are not limited to:

• Manage and oversee the trial activities including development/revision  of the final protocol/addendums, template informed consent for site use, study manual of operations, CRF guidelines and study training materials
• Oversee and manage the logistics around a new site start-up, including activities such as finalizing customized informed consents, finalizing and submitting IRB submissions and respond to queries, reviewing site regulatory documents, negotiating budget terms etc.  
• Oversee the operations of the clinical trial sites, and serve as the primary liaison with principal investigator
• Assist in the development of strategic planning to ensure proper business development activities, with the PI and Program Director
• Prepares reports on status of sites with regards to activation, recruitment and close-out. Follows up and resolves issues as it relates to processing of site contracts
• Oversees and leads the site/regional regulatory submissions and updates through life of trial
• Prepares and issues reports within established procedures. Analyses findings of central review and monitor site source documents, and presents recommendations. Prepares and review documents independently and generates status/progress reports, collaborating with data management and sites to resolve site issues.
• Oversees and coordinates all site study start-up, conduct, and close-out activities
• Acts as the primary liaison and resource to assigned sites for protocol related questions and GCP related matters
• Coordinates and oversees activities of study core labs, or external vendors, as applicable.
• Develop, implement, monitor, and support Standard Operating Procedures (SOPs) and work processes to ensure the efficient clinical operation of the CCC
• Develops, prepares and revises training materials, develops curriculum, database management and ensures satisfaction through various measurement tools.
• Attends and co-leads training meetings/webinars, team meetings as required
• Oversee help desk tickets submitted by sites within network
• Recruit, hire, train and supervise Clinical Research Associates, Clinical Trial Assistants and/or Project Assistants, and ensures all policies and procedures are being adhered to and implemented. Responsible for completing annual performance reviews through ePerformance.

This position requires a self-starter with strong organizational skills who has familiarity with ICH/GCP and has experience in US and or international clinical research site management. Remote work will be considered for this position.

MINIMUM QUALIFICATIONS: To qualify you must have a Bachelors degree in healthcare or sciences preferred with a minimum of 5 years experience in an academic healthcare or pharmaceutical company setting. Clinical trial management experience within and/or outside the USA is required. Proficiency with Microsoft Office and Excel. Effective verbal and written communication skills.

Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. NYU Grossman School of Medicine 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, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision. We require applications to be completed online. If you wish to view NYU Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.

Required Skills Required Experience