Clinical Research Coordinator II- (PrIISM) Immunology and Immunotherapy

Mount Sinai Health System • New York, NY

7d

About The Position

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.

Requirements

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

Nice To Haves

• 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.
• Advanced experience with Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and EMR (e.g., Epic) data extraction.
• Exceptional ability to maintain rigorous documentation standards, essential for the high-intensity data requirements of cellular therapy trials.
• Strong interpersonal skills to manage relationships with high-acuity patients and diverse clinical teams (physicians, lab scientists, pharmacists, and regulatory bodies).
• Ability to navigate the dynamic challenges of translational research, including protocol deviations, enrollment hurdles, and unforeseen clinical events.

Responsibilities

• 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.
• Manage participant recruitment, screening against complex eligibility criteria, informed consent processes, and longitudinal monitoring of subjects in non-cancer clinical trials.
• Ensure all trial activities strictly adhere to GCP (Good Clinical Practice), FDA 21 CFR Part 312 regulations, and HIPAA guidelines.
• Oversee the collection, abstraction, and meticulous documentation of clinical data, including adverse event (AE) reporting, concomitant medication logs, and complex 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" at all times.
• Proactively manage data queries from sponsors or monitors, ensuring timely and accurate resolution of data discrepancies.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level