Job Description

Supervises and coordinates the collection, entry and retrieval of clinical and research data for the department

Protocol development activities: collaborate with investigators in all phases of protocol development.

 Develop investigator-initiated projects

 Coordinate and communicate with investigators and members of the research team to aid in study development and oversight throughout the life-cycle of clinical trial  Understand scientific terminology

 Understand hospital, local, state, and federal regulatory requirements

 Create protocol study documents (informed consent forms, case report forms, brochures, pamphlets, etc.)

 Coordinate all aspects of protocol submission for research projects

 Understand scientific pre-clinical and clinical data applied to the conduct of clinical trials  Collaborate with study team to ensure study feasibility

Regulatory activities: oversee the regulatory processes for projects.

 Prepare and submit protocol application for IRB review

 Track protocol application status through RUTH, GCO and InfoEd systems

 Respond to inquiries for clarification  Gather clinical and safety data needed for annual IRB review

 Investigational New Drug (IND) Applications

 Study budget as needed

 Update and maintain clinical trial status on clinicaltrials.gov website

 Maintain/distribute regulatory documents  Work with study sponsors

 Prepare reports for various hospital and regulatory offices of research activities

 Research Liaison

 Provide assistance to residents, fellows and students in the application process

 Log and track study team regulatory documents

 Work in CTSU, Imedidata and other regulatory systems

Clinical Research Coordinator activities: project maintenance, planning and reporting.

 Hold Site Initiation Visits in preparation for study opening

 Review/confirm subject eligibility

 Work with the research team to facilitate the enrollment of research subjects

 Perform central subject registration with CCTO and ONCORE.

 Monitor patient timeline for protocol compliance

 Track and alert all study team members of patient research appointments

 Identify/collaborate with PI to report Serious Adverse Events

 Train research team members on subject registration, regulatory processes and procedures and protocol compliance

 Serve as the resource for detailed information on all studies

 Maintain electronic and hard copy files

 Work with all phases of clinical trials (start up to conclusion)

Data Management/Analysis activities: create, manage and protect departmental research systems by organizing, storing, and analyzing data.

 Data entry and maintenance (prospective vs retrospective)

 Create databases

 Data acquisition

 Data Mining

 Review and prepare data from various sources

 Data Cleaning  Exploratory Data analysis

 Data Visualization

 Work with all levels of staff in data abstraction/form creation

 Data validation  Proficient in the use of computer programs

 Identify all relevant source documents for abstraction and recording

 Other data management responsibilities as needed

 SPSS, REDCap, SAS, R for data management/analytical activities

 Work with team members in the IRB (RUTH submissions), InfoED/IDEATE, GCO, DFG, PRMC

HS Diploma

Compensation Statement

The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $59,267.00 - $88,900.00 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.

Non-Bargaining Unit, BVE - Radiology Oncology - USD, Union Square - Downtown

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.

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 — 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.

Equal Opportunity Employer

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.