Job Description
Strength Through Diversity
Ground breaking science. Advancing medicine. Healing made personal.
Roles & Responsibilities:
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.
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 meetings.

Qualifications

• Bachelors degree in sciences or related field.
• 2 years of clinical research
• Working knowledge Good Clinical Practice guidelines and Federal research regulations.
• Strong understanding and knowledge base of coordination requirements associated with industry funded clinical trials.
• 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
Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai's unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:

• Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.
• Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.
• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization. We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally.

Explore more about this opportunity and how you can help us write a new 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 43,000 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 approximately 7,400 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 and top 20 in Cardiology/Heart Surgery, 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. 14 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.

The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism."

EOE Minorities/Women/Disabled/Veterans