Job Title

Job Description 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. 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. Qualifications + Bachelors degree in sciences or related field. + 2 years of clinical research Responsibilities Coordinates activities of ongoing clinical trials: u2022 Assists in the activities related to clinical research studies including but not limited to: answering phone calls, screening participants for eligibility, administering lifestyle questionnaires. u2022 Obtain informed consent under supervision of the study investigator(s) u2022 Educate potential participants regarding study requirements. u2022 Screen patients for eligibility though through medical record review u2022 Coordinate research team to ensure compliance with planned treatment protocol including required laboratory and radiographic testing. u2022 Secure, deliver, and ship blood and/or tissue samples, radiographs, and other clinical specimens as required by protocol. u2022 Act as liaison between investigator(s) and study sponsor. u2022 Coordinate activities pertinent to the safeguarding of patientsu2019 rights in research. Manage study data of ongoing clinical trials under supervision of the Principle Investigator(s): u2022 Ensure accurate and complete compilation of subject data through chart reviews. u2022 Collect and record study data on Case Report Forms (CRFs) and submit forms in a timely manner according to study guidelines. u2022 Meet with internal and sponsor appointed monitors to ensure accuracy of subject data and compliance with research protocol. u2022 Maintain source documents and subject files in accordance with Mount Sinai School of Medicine (MSSM) Standard Operating Procedures (SOPs). u2022 Oversee subject recruitment and study enrollment goals. Determine effective strategies for recruiting research participants and retaining participants in long-term clinical trials. u2022 Assist with analyzing data as needed. Ensure proper compliance with institutional and regulatory requirements: u2022 Report adverse events and serious adverse events in accordance with MSSM Institutional Review Board (IRB) SOPs, sponsor guidelines, and federal regulations u2022 Assist the PI and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing clinical trials u2022 Interacting with the regulatory team to maintain regulatory documentation and administrative files for each protocol. u2022 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: u2022 Participate in Investigatorsu2019 Meeting and assist with coordinating Study Initiation Visits. u2022 Attend divisional/departmental/institutional educational and training seminars. u2022 Facilitate sponsor monitoring visits. u2022 Educate new staff regarding overview of clinical research, office policy and procedures, data submission, workflows and specimen handling. u2022 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 meetings. 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 Sinaiu2019s 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. At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history. 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 u2014 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 patientsu2019 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