Clinical Research Coordinator II - Medicine Clinical Trials Office

Under minimal supervision, coordinates the clinical assessments of the study subjects; analyzes and assists in interpreting moderately complex clinical research data. Prepares grant applications and documents and assists in protocol submissions (for e.g., Institutional Review Board, Grants and Contracts Office).

A Clinical Research Coordinator (CRC) II position is currently available within the Medicine Clinical Trials Office. Responsibilities 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.

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, administering lifestyle questionnaires.
• Obtain informed consent under supervision of the study investigator(s)
• Educate potential participants regarding study requirements.
• Screen patients for eligibility though through medical record review
• 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 study sponsor.
• 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).
• Oversee subject recruitment and study enrollment goals. Determine effective strategies for recruiting research participants and retaining participants in long-term clinical trials.
• Assist with analyzing data as needed.

Ensure proper compliance with institutional and 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
• Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol.
• Regularly inspect study document to ensure ongoing regulatory compliance. The coordinator will also comply with necessary regulatory responsibilities.

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.
• Facilitate sponsor monitoring visits.
• Educate new staff regarding overview of clinical research, office policy and procedures, data submission, workflows and specimen handling.
• Under the supervision of the clinical research manager, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meeting.

Qualifications

• Bachelors degree in sciences or related field.
• 2 years of clinical research

Preferred:
Working knowledge Good Clinical Practice guidelines and Federal research regulations.
• Strong understanding and knowledge base of coordination requirements associated with industry funded clinical trials and working
• Demonstrated strong organizational and communication skills.
• Must be comfortable communicating clinical information to medical personnel.
• Proven organizational skills including attention to detail and multi-tasking skills
• Ability to work within a team environment as well as independently
• Ability to identify, analyze and solve problems while working under pressure
• Strong computer literacy required.

About Us

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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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