Clinical Research Coordinator II - Tisch Cancer Center

A Clinical Research Coordinator (CRC) II position is currently available within the Tisch Cancer Center. Duties will include activities such as data collection and management of patient clinical information, timely collection of protocol related samples including shipment to outside entities as required, obtain informed consent, collect, maintain and organize study information, and assist with other day-to-day operations as required. Under minimal supervision, the Clinical Research Coordinator II will manage a workload that includes studies of increased complexity.

The Tisch Cancer Center 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

Coordinates activities of ongoing clinical trials:

• Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, registering subjects with sponsoring agency, administering lifestyle questionnaires.
• Obtain informed consent under supervision of the study investigator(s); educate participants regarding study requirements.
• Screen patients for eligibility and register subjects with sponsoring agency.
• Coordinate research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing.
• Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol.
• Act as liaison between investigator(s) and sponsoring agency.
• Coordinate activities pertinent to the safeguarding of patients' rights in research.

Manage study data of ongoing clinical trials under supervision of the Principle Investigator(s):

• Ensure accurate and complete compilation of subject data through chart reviews.
• Collect and record study data on Case Report Forms (CRFs) and submit forms in a timely manner according to study guidelines.
• Meet with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol.
• Maintain source documents and subject files in accordance with Mount Sinai School of Medicine (MSSM) Standard Operating Procedures (SOPs).
• Assist with analyzing data as needed.

Ensure proper compliance with institutional and national regulatory requirements

• Report adverse events and serious adverse events in accordance with MSSM Institutional Review Board (IRB) SOPs, sponsor guidelines, and federal regulations
• Assist the PI and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials

Performs other job related duties as required, which may include but not limited to:

• Participate in Investigators' Meeting and assist with coordinating Study Initiation Visits.
• Attend divisional/departmental/institutional educational and training seminars.
• Contact local physicians to obtain source documentation and subject survival status.
• Educate new staff regarding overview of clinical research, office policy and procedures, data submission, patient registration and specimen handling.

Qualifications

• Bachelors degree in sciences or related field.
• 2 years of clinical research
• Preferred:
  • Working knowledge Good Clinical Practice guidelines and Federal research regulations
  • Demonstrate strong organizational and communication skills.
  • Oncology experience preferred.
  • Must be comfortable communicating clinical information to medical personnel.
  • Strong computer literacy required.

About Us

Strength through Unity and Inclusion

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai's unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.

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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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The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.