PrIISM is seeking an experienced and highly organized Clinical Research Coordinator II to manage the complex daily operations of our Cellular Therapy Clinical Research Program. The successful candidate will focus on non-cancer cellular therapy trials (e.g., autoimmune, inflammatory, or rare genetic diseases). Reporting into the CT Program Director, you will serve as the clinical operational lead, ensuring the highest standards of protocol adherence, data integrity, and patient safety in a high-stakes environment involving complex investigational products.

Responsibilities

Clinical Operations & Study Management

• Protocol Execution: Lead the end-to-end management of complex cellular therapy protocols, ensuring all clinical procedures (e.g., cell infusion, specialized monitoring, longitudinal follow-ups) are performed according to the protocol and institutional standards.
• Patient Coordination: Manage participant recruitment, screening against complex eligibility criteria, informed consent processes, and longitudinal monitoring of subjects in non-cancer clinical trials. 
• Quality Assurance: Ensure all trial activities strictly adhere to GCP (Good Clinical Practice), FDA 21 CFR Part 312 regulations, and HIPAA guidelines. 

Data Collection & Management

• Advanced Data Stewardship: Oversee the collection, abstraction, and meticulous documentation of clinical data, including adverse event (AE) reporting, concomitant medication logs, and complex biomarker analysis schedules.
• Data Integrity: Maintain source documentation and electronic Case Report Forms (eCRFs). Perform regular internal audits and quality control checks to ensure data is "audit-ready" at all times. 
• Query Resolution: Proactively manage data queries from sponsors or monitors, ensuring timely and accurate resolution of data discrepancies. 

Qualifications

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

Preferred Skills

• Bachelor’s degree in a health-related field (or equivalent). Advanced degree (Master’s) is highly desirable.
• Minimum of 3–5 years of clinical research experience, with at least 1–2 years specifically in clinical operations, complex data management, or cellular/biological therapies.
• Technical Proficiency: Advanced experience with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and EMR (e.g., Epic) data extraction.
• Attention to Detail: Exceptional ability to maintain rigorous documentation standards, essential for the high-intensity data requirements of cellular therapy trials. 
• Communication: Strong interpersonal skills to manage relationships with high-acuity patients and diverse clinical teams (physicians, lab scientists, pharmacists, and regulatory bodies). 
• Problem-Solving: Ability to navigate the dynamic challenges of translational research, including protocol deviations, enrollment hurdles, and unforeseen clinical events.

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.