Senior Clinical Research Coordinator - Tisch Cancer Institute

A Senior Clinical Research Coordinator position is available within the Tisch Cancer Institute. The Senior Clinical Research Coordinator will work with Principle Investigators (PIs), Research Manager and Clinical Research Team to manage data associated with cancer clinical research protocols.

Under general supervision, analyzes and interprets highly complex clinical research data; conducts clinical testing and develops protocols. Develops work flow policies and procedures. Mentors, trains and reviews the work of less experienced clinical research staff. Oversees the clinical assessments of the study subjects.  Assists with protocol submissions, database enhancements, and budget preparation.

The Tisch Cancer Institute is a vital component of the Icahn School of Medicine at Mount Sinai Hospital and plays a key role in the Mount Sinai Health System, which is one of the largest health care systems in the nation.   We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer.  

• Participate in Clinical Trial Feasibility, Site Selection Process and Site Initiation Visit.
• Portfolio will include but not limited to complex, first-in-human Phase 1 and Phase 2 trials.
• Coordinate patient care with ancillary department such as pathology, interventional radiology, immune monitoring core, clinical laboratory, surgery, stem cell lab, transplant team and clinical services including RTC, and inpatient floors.
• Pre-Screen patients by conducting Medical Records review.
• With input from PIs and Research RNs, create and maintain Standard Operating Procedures (SOPs) specific for each study.
• Coordinate the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects.           
• Prompt PIs, Research Team including Research RNs about protocol requirements for upcoming study visits.
• Collect required data and maintain the data management database.
• Design specific projects data sets, including the selection of appropriate methods and techniques to capture in case report forms.
• Track and maintain Investigator New Drug Safety Reports and identify trends in adverse events.
• Assist in preparing and ensuring that grant applications and IRB/GCO documents are submitted.
• Coordinates protocols and human subject approvals between various sites.          
• Assist the Principal Investigator and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials.                   
• Mentors, trains and reviews the work of CRC I and CRC II and CRC at other sites for multi-center trials.
• Develops work flow policies and procedures for assigned trials.
• Prepares reports for presentation in conferences and seminars.       
• Oversees data collection, processing, storage, inventory and quality control for clinical research studies.                       
• Assists in budget preparation and negotiation and assure research billing compliance. 
• Prepare and participate in external audits including FDA audits.
• Perform other duties assigned. 
                                                         
   

• Bachelors degree in sciences or related field. Masters degree preferred
• 5 years of clinical research

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:  

• Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.
• Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.
• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

We work hard to acquire and retain the best people and to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to professional advance. We share the belief that all employees, regardless of job title or expertise contribute to the patient experience and quality of patient care.

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