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About the Role

PrIISM is seeking an experienced and highly organized Clinical Research Coordinator II to manage the complex daily operations of the Cellular Therapy Clinical Research Program, focusing on non-cancer cellular therapy trials. The role serves as the clinical operational lead, ensuring protocol adherence, data integrity, and patient safety.

Responsibilities

• Lead the end-to-end management of complex cellular therapy protocols, ensuring all clinical procedures are performed according to protocol and institutional standards.
• Manage participant recruitment, screening, informed consent, and longitudinal monitoring for non-cancer clinical trials.
• Ensure all trial activities adhere to GCP, FDA 21 CFR Part 312 regulations, and HIPAA guidelines.
• Oversee the collection, abstraction, and documentation of clinical data, including AE reporting, concomitant medication logs, and biomarker analysis schedules.
• Maintain source documentation and electronic Case Report Forms (eCRFs).
• Perform regular internal audits and quality control checks to ensure data is audit-ready.
• Proactively manage data queries from sponsors or monitors, ensuring timely and accurate resolution of data discrepancies.

Requirements

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

Skills

• Advanced experience with Electronic Data Capture (EDC) systems.
• Advanced experience with Clinical Trial Management Systems (CTMS).
• Advanced experience with EMR (e.g., Epic) data extraction.
• Exceptional ability to maintain rigorous documentation standards.
• Strong interpersonal skills to manage relationships with high-acuity patients and diverse clinical teams.
• Ability to navigate the dynamic challenges of translational research.

Location

• New York metro area

Work Type

• Full-time

Experience Level

• 3-5 years of clinical research experience
• 1-2 years specifically in clinical operations, complex data management, or cellular/biological therapies

Education Level

• Bachelor’s degree in health-related field (or equivalent)
• Advanced degree (Master’s) is highly desirable

Salary/Compensations

• $66199.98 - $90000.04 Annually

About the Company

• The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence and deliver outstanding patient care.
• Mount Sinai's legacy of achievement, education, and innovation aims to transform healthcare.
• The organization encourages active participation in creating a culture of fair access to opportunities, inclusive practices, and individual success.
• Leaders are committed to fostering a workplace where employees feel valued, respected, and empowered to grow.
• The environment promotes collaboration, fairness, and continuous learning to improve staff, patient, and organizational well-being.
• Leaders are expected to challenge outdated practices and promote respect to enhance patient care and workplace experiences.
• Mount Sinai Health System is one of the largest academic medical systems in the New York metro area.
• It comprises over 48,000 employees across eight hospitals, more than 400 outpatient practices, and over 300 labs.
• It includes a school of nursing and a leading school of medicine and graduate education.
• Mount Sinai advances health by addressing complex healthcare challenges, discovering new scientific knowledge, developing safer treatments, educating future medical leaders, and supporting communities with high-quality care.
• The system integrates hospitals, labs, and schools to offer comprehensive health care solutions.
• Innovative approaches like artificial intelligence and informatics are leveraged, with patient needs at the center of treatment.
• The Health System includes over 9,000 physicians, 13 joint-venture outpatient surgery centers, and over 30 affiliated community health centers.
• It is consistently ranked by U.S. News & World Report's Best Hospitals and is highly ranked in multiple specialties.
• The Icahn School of Medicine at Mount Sinai is highly ranked for NIH funding and research dollars.
• Newsweek ranks The Mount Sinai Hospital and Mount Sinai Morningside among the world's best smart hospitals.

Equal Opportunity

• 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 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.