Senior Clinical Research Coordinator - Tisch Cancer Center

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.

Responsibilities

• 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 Pls, 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.

Qualifications

• Bachelors degree in sciences or related field. Masters degree preferred
• 5 years of clinical research
• Preferred:
  • Excellent written and oral communication skills
  • Exceptional attention to detail and accuracy
  • Ability to manage multiple tasks & priorities
  • Demonstrated leadership potential

About Us

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About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients' medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report's "Best Children's Hospitals" ranks Mount Sinai Kravis Children's Hospital among the country's best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek's "The World's Best Smart Hospitals" ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

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