Job title: Clinical Study Coordinator Location: Santa Monica CA 90404/ El Segundo, CA 90245 Hybrid Duration: 12 months contract Position Summar yThis role supports Medical Affairs activities related to Expanded Access Programs (EAPs), Out-of-Specification (OOS) case support, and Single-Patient IND processes. The individual will contribute to the operational execution of treatment-use and clinical support activities by coordinating program deliverables, managing vendors and external partners, supporting investigator and site communications, tracking milestones and risks, and ensuring compliance with applicable regulations and internal procedures Key Responsibiliti esMay assist in the review of study-related and essential start-up documents, as delegated by the study manager, including clinical protocols, informed consent forms, investigator brochures, pharmacy manuals, monitoring plans, case report forms, CRF completion guidelines, and other relevant study plans and charter s.With guidance, plays a direct role in clinical study and program execution by managing assigned components of studies or expanded access activities and serving as a member of the study tea m.Supports activities associated with out-of-specification programs, expanded access programs, and single-patient IND requests, including coordination of timelines, documentation, communications, and cross-functional follow-u p.Manages vendors and works with multiple contract research organizations and external partners to communicate detailed timelines, oversee transferred obligations, and ensure performance expectations are met; provides corrective instruction as needed when expectations are not me t.Attends internal team meetings and other required meetings to support program planning, issue resolution, and executio n.Provides training, as needed, at investigator meetings and other trial- or program-specific meetings, such as site initiation visits and monthly teleconference s.Creates and reviews site feasibility assessments required for participation, where applicabl e.Manages and tracks key deliverables such as screening, enrollment, data flow, protocol deviations, and other program milestone s.Proactively identifies potential study or program issues and risks, recommends and implements solutions, and escalates issues appropriately to senior managemen t.Prepares metrics and status updates on key deliverables for management revie w.Assists in the resolution of clinical trial queries for interim analyses, primary analyses, and final database locks, as applicabl e.Prepares site newsletters and other correspondence related to clinical trial or program conduct, including best practices, lessons learned, and frequently asked questions, in collaboration with the study tea m.Assists in the resolution of routine questions from clinical trial sites and external stakeholders in adherence to ICH GCP, study protocols, and applicable treatment-use requirement s.May participate in special projects and other duties as assigne d.Applies standard medical and scientific terminology appropriately in support of documentation, communication, and operational executio n. Basic Qualificati onsBachelor's degree (BS/BA) or Registered Nurse (RN) in Nursing, Science, or a related healthcare fie ld.3–5 years of relevant experience in clinical operations, medical affairs, or a related ar ea. Preferred Qualificat ionsExperience in Oncology/Hematology (preferr ed).Cellular therapy experience is a p lus.Experience with iMedidata/RAVE EDC systems is desira ble.Prior study start-up experience from a: Site-based regulatory role, Contract Research Organization (CRO) or Sponsor organiza tion Required Skills Compete nciesStrong analytical and problem-solving abili ties.Excellent organizational and multitasking sk ills.High attention to de tail.Ability to manage competing time demands, incomplete information, and unexpected situat ions.Excellent verbal, written, and interpersonal communication sk ills.Ability to work effectively in a collaborative, fast-paced environment with minimal supervi sion.Flexibility to adapt to changing priorities and workl oads.Knowledge of transplant patient care and apheresis collection is a plus.
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