div class="job-description-container">The National Institute of Clinical Research (NICR) is an independent, multi-site clinical trial site management organization (SMO). NICR combines the use of the latest technologies, streamlined clinical operations, and extensive access to a diverse population to deliver the highest quality clinical trials for life-changing therapies.
p>ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. Senior Clinical Research Associate will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.
Huntington Beach, California30 days ago
As a Clinical Research Manager, you will own end-to-end US IDE study operations, leading a team of clinical research professionals, ensuring regulatory compliance across all active sites, and driving the clinical strategy that will help bring the world’s first Total Artificial Heart to patients who need it most. Collaborate on clinical strategy and author key clinical documents including clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, risk-benefit analyses, and clinical marketing materials.
Orange, California10 days ago
p style="margin:0px">The UCI Center for Clinical Research (CCR) is full service clinical trials unit serving a diverse array of clinical trials across 20 clinical departments, alongside the Stern Center for Clinical Trials and Cancer Research (cancer clinical trials) and the Alpha Clinic (cell and gene therapies). *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
How you will make an impact: Field monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determining if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. Developing and delivering technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities.
Huntington Beach, California30 days ago
Your collaboration with clinical sites is critical to ensuring trials are conducted ethically while adhering to protocol, applicable regulations, and guidelines — helping us move closer to putting the world’s first Total Artificial Heart into the hands of patients who need it most.
Los Angeles, CA30+ days ago
p>Arranges admission to the Clinical Trials Unit (CTU) at University Hospital so that samples can be obtained For other research blood draws: At Norris, fills out specimen request slips and coordinates the drawing of specimens with the clinical lab, processes samples after blood is drawn, and stores at the appropriate temperature. If you are a current USC employee, please apply to this USC job posting in Workday by copying and pasting this link into your browser:
https://wd5.myworkday.com/usc/d/inst/1$9925/9925$146168.htmld.
Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate.
Anaheim, California27 days ago
p>Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate.
Anaheim, California30+ days ago
p>The Clinical Research Coordinator works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following: changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
Bellflower, CA30+ days ago
Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies.
Bellflower, CA15 days ago
Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate.
Bellflower, California30+ days ago
li>Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies.
p>The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors. The NCI-designated Chao Family Comprehensive Cancer Center (CFCCC) is a campus-wide multidisciplinary matrix organization whose goal is to promote and enhance cancer-relevant research and patient care at UC Irvine.
Los Alamitos, CA13 days ago
Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies.
Under policy direction from the Practice Manager and Lead Coordinator, and with the support of the COO, the Clinical Research Assistant will play a crucial role in supporting clinical research activities, ensuring adherence to protocols, and contributing to the advancement of medical knowledge. The Clinical Research Assistant is responsible for drawing blood, performing lab tests, scheduling patients, tracking patient data and performing other clerical duties for the office.
Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including: Submission documents/approval, Protocol amendments with respective signature pages, Informed consent documents, FDA form 1572, Lab normal result documents, financial disclosure forms, Delegation of authority logs, Licenses, Reports. With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs.
Anaheim, California30+ days ago
ul>Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including: Submission documents/approval, Protocol amendments with respective signature pages, Informed consent documents, FDA form 1572, Lab normal result documents, financial disclosure forms, Delegation of authority logs, Licenses, Reports. With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs.
Fountain Valley, CA12 days ago
You will work closely with a Director of Operations, a team of approximately 7-10 Clinical Research Coordinators, and 3 Research Assistants, each with a defined focus area; this role focuses primarily on IT and technology support while also contributing to clinical and administrative tasks. The Clinical Research Assistant ensures that all study-related technology functions smoothly while also assisting Clinical Research Coordinators with patient-facing tasks and routine clinical procedures.