Clinical Research Coordinator II- (PrIISM) Immunology and Immunotherapy

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.

Full time · Day shift