Senior Clinical Research Coordinator - Tisch Cancer Center

About the Role

The Senior Clinical Research Coordinator will work within the Tisch Cancer Institute, a vital component of the Icahn School of Medicine at Mount Sinai Hospital and a National Cancer Institute (NCI)-designated center. This role involves managing data associated with cancer clinical research protocols, developing work flow policies and procedures, and mentoring less experienced clinical research staff.

Responsibilities

• Participate in Clinical Trial Feasibility, Site Selection Process, and Site Initiation Visit.
• Manage a portfolio including complex, first-in-human Phase 1 and Phase 2 trials.
• Coordinate patient care with ancillary departments 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.
• Create and maintain Standard Operating Procedures (SOPs) specific for each study with input from PIs and Research RNs.
• Coordinate the clinical assessments of study subjects, including screening and evaluation.
• Prompt PIs and the Research Team about protocol requirements for upcoming study visits.
• Collect required data and maintain the data management database.
• Design specific projects data sets, including selecting appropriate methods and techniques for case report forms.
• Track and maintain Investigator New Drug Safety Reports and identify trends in adverse events.
• Assist in preparing and submitting grant applications and IRB/GCO documents.
• Coordinate protocols and human subject approvals between various sites.
• Assist the Principal Investigator and regulatory staff in preparing new protocol submissions, amendments, and renewals.
• Mentor, train, and review the work of CRC I, CRC II, and CRCs at other sites for multi-center trials.
• Develop work flow policies and procedures for assigned trials.
• Prepare reports for presentation at conferences and seminars.
• Oversee data collection, processing, storage, inventory, and quality control for clinical research studies.
• Assist in budget preparation and negotiation, ensuring research billing compliance.
• Prepare for and participate in external audits, including FDA audits.
• Perform other assigned duties.

Requirements

• Bachelor’s degree in sciences or related field. Master’s degree preferred.
• 5 years of clinical research experience.

Skills

• Excellent written and oral communication skills.
• Exceptional attention to detail and accuracy.
• Ability to manage multiple tasks and priorities.
• Demonstrated leadership potential.

Pay

The salary range for this role is $72,880.95 - $116,693 annually. Actual salaries depend on experience, education, and operational need.

About the Employer

The Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with over 48,000 employees across eight hospitals, more than 400 outpatient practices, and over 300 labs. It includes a leading school of medicine and graduate education, and is committed to fostering an inclusive environment where everyone can contribute to excellence in patient care, research, and education.