clinical research associate i, field monitor

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clinical research associate Jobs in California

clinical research associate

clinical research associate i, field monitor Jobs in California

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clinical research associate, in-house

clinical researcher

clinical data scientist

Harnham

<div>
 
 
 Clinical Data Scientist
 
 
 
 
 Location:
 
 Hybrid (San Francisco, CA) or Fully Remote in PST
 
 
 
 
 
 
 About the Company
 
 
 
 Our client is a data-driven company transforming how clinical insights are generated and applied in cancer research. By integrating advanced analytics with real-world patient data.
 
 
 
 
 
 
 Role Overview
 
 
 
 We are seeking a
 
 Clinical Data Scientist
 
 with deep experience in clinical research, oncology data, and statistical analysis. You&rsquo;ll work cross-functionally with biostatistics, data management, and clinical operations teams to design, analyze, and interpret datasets from clinical trials with a focus on cancer studies, RECIST criteria, and survival analysis.
 
 
 Key Responsibilities
 
 <ul>
 <li>
 Design, clean, and analyze clinical trial data in compliance with CDISC standards (SDTM, ADaM).
 </li>
 <li>
 Develop and implement reproducible statistical analysis pipelines using
 
 SAS, R, and Python
 
 .
 </li>
 <li>
 Create data queries, reports, and visualizations to communicate findings to clinical and research teams.
 </li>
 <li>
 Work with cross-functional stakeholders to define data requirements and ensure accuracy and consistency.
 </li>
 <li>
 Support statistical analysis plans, including modeling for survival analysis and effectiveness endpoints.
 </li>
 <li>
 Manage and version control data workflows using
 
 Git
 
 or similar tools.
 </li>
 <li>
 Ensure compliance with
 
 HIPAA
 
 and internal data privacy standards.
 </li>
 </ul>
 
 
 
 
 
 Qualifications
 
 
 <ul>
 <li>
 
 3+ years of experience
 
 in clinical data science or biostatistics, ideally within oncology or related domains.
 </li>
 <li>
 Hands-on experience with
 
 SAS
 
 ,
 
 R
 
 ,
 
 Python
 
 , and
 
 SQL
 
 for data manipulation and analysis.
 </li>
 <li>
 Solid understanding of
 
 CDISC SDTM
 
 and
 
 ADaM
 
 data standards.
 </li>
 <li>
 Experience analyzing oncology endpoints such as
 
 RECIST
 
 and
 
 survival analysis
 
 .
 </li>
 <li>
 Strong understanding of
 
 clinical trial design
 
 , data management principles, and regulatory data standards.
 </li>
 <li>
 Familiarity with
 
 HIPAA
 
 compliance and healthcare data safeguards.
 </li>
 <li>
 Proficiency with version control (e.g.,
 
 Git
 
 , GitHub).
 </li>
 <li>
 Advanced degree (Master&rsquo;s or higher) in
 
 Biostatistics, Data Science, Epidemiology, or related field
 
 .
 </li>
 </ul>
 
 
</div>

Clinical Data Scientist

Sierra Management and Technologies Inc

<div>The Organization: Sierra Management and Technologies, Inc.
Sierra Management and Technologies, Inc. (Sierra), provides unparalleled logistics and program management, cutting-edge software and IT system development, and innovative data science and analytics services to our Department of Defense clients as well as superior support to Government Contracting Facility Security Officers (FSO).
As a disadvantaged, minority-owned, small business, we are committed to exceeding expectations and fostering excellence within our workforce. Sierra has a proud history of hiring veterans and encourages those who have served in the armed forces to apply.
Sierra is an honored recipient of the following awards:<div><ul><li>
HIRE Vets Medallion Award</li><li>
VETS Indexes Employer Award</li></ul></div>
About the Role:
Sierra Management and Technologies is recruiting for a Data Scientist to provide support for the NAWCAD Readiness &amp; Fleet Analytics (R&amp;FA) Division&rsquo;s Advanced Analytics and Innovation (AA&amp;I) Branch at Patuxent River Naval Air Station in Lexington Park, MD. This candidate will primarily involve migrating code for data science projects from Cloudera Data Science Workbench (CDSW) to Databricks. The candidate will use business intelligence (BI) tools such as Tableau and Microsoft Power BI to transform PMA reliability, maintenance, and supply data into actionable insights. Additionally, you will work with cutting-edge data engineering, web development, and data science platforms, including Databricks, GitLab, JIRA, Amazon Web Services (AWS), NUCLEUS, and JAVA, to deliver innovative and impactful solutions. The AA&amp;I Branch provides critical support to Program Management Air (PMA) offices, the Air Systems Group, Command, Fleet Readiness Centers, and other Department of Defense (DoD) services.
Key Responsibilities:<ul><li>
Apply advanced analytical models, techniques, and methodologies to solve complex scientific and business operations challenges.</li><li>
Dashboard &amp; Visualization Development: Research, design, and develop user-centric interactive reports, dashboards, and visualization solutions using Tableau, Qlik, or Power BI to deliver actionable business insights for PMA and AA&amp;I branch decision makers.</li><li>
Technical Proficiency &amp; Analysis: Demonstrate expertise in scientific tools including QLIK, Tableau, R, Python, and SQL, along with other programming and dashboarding utilities. Analyze aircraft platforms and develop algorithms to detect system failures and performance issues.</li><li>
Data Engineering &amp; Architecture: Design, build, integrate, and manage data architecture and frameworks for various data science projects, ensuring seamless data flow between servers and applications.</li><li>
Data Management &amp; Processing: Gather, clean, preprocess, and analyze data from multiple sources to support modeling and decision-making processes. Apply statistical analysis and data mining techniques to extract insights, validate model assumptions, and develop automated scripts for data transmission across different environments.</li><li>
Advanced Analytics: Apply machine learning, natural language processing, and other advanced programming techniques to collect, process, analyze, and present statistical data in meaningful formats.</li><li>
Predictive Analytics: Analyze historical data and trends to forecast future outcomes and continuously optimize model performance.</li></ul>
What Makes a Successful Candidate:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Must Have:<ul><li>
Bachelor's degree in Data Science, Computer Science, Mathematics, Statistics (preferred), or Engineering/Operations Research (acceptable) with 3+ years of related experience. Master's degree preferred and will receive preference.</li><li>
Programming Expertise: 3+ years of professional or academic experience with Python, R, or SQL.</li><li>
Business Intelligence Tools: 3+ years of hands-on experience with Tableau, Qlik, or Power BI.</li><li>
Project Management Tools: 3+ years of experience with JIRA and GitLab.</li><li>
Secret security clearance</li><li>
U.S. Citizen.</li></ul>
Applicants must be authorized to work in the U.S. without sponsorship and be able to obtain a security clearance.
Nice to have:<ul><li>
Background in aerospace and/or defense industries</li><li>
Familiarity with aviation industry data</li><li>
JAVA and front-end development skills</li><li>
Advanced Tableau data visualization expertise</li><li>
Scrum Master certification and/or leadership experience</li><li>
Strong analytical and critical thinking capabilities</li><li>
Excellent oral and written communication skills, including the ability to present and defend technical recommendations</li><li>
Self-directed team player with proven ability to deliver results efficiently and interact professionally across all management levels</li><li>
High-level problem-solving and interpersonal skills</li><li>
Adaptability to work effectively in dynamic environments</li></ul>
What to expect in our process<ul><li>
Apply by submitting a cover letter and resume for the position</li><li>
Interview with the Hiring Manager</li><li>
Reference checks and degree verification</li><li>
Offer</li></ul>
We take care of our employees by providing the following benefits:<ul><li>
Flexible work schedules and remote/hybrid opportunities (depending on the role)</li><li>
Medical, dental, and vision insurance</li><li>
Flexible spending account and health savings account options</li><li>
Dependent care flexible spending account</li><li>
Education reimbursement</li><li>
Voluntary insurance such as: short-term disability, hospital indemnity, critical illness, and accident insurance</li><li>
100% company-paid life + AD&amp;D and long-term disability insurance</li><li>
Generous paid time off policy</li><li>
11 paid holidays</li><li>
401(k) retirement plan with matching contributions</li><li>
Employee assistance program</li></ul>
Equal Opportunity Statement
Building an inclusive, high-performing team that is diverse across lines of personal identity is integral to our success, and we are proud to be an equal-opportunity employer.
This means we do not discriminate against any job applicant or employee because of their race, ethnicity, color, religion, national origin, sex, disability status, genetics, protected veteran status, gender identity or expression, sexual orientation, age, or any other characteristic protected by federal, state, or local laws. This applies to all terms and conditions of employment.
E-Verify Statement
This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, this employer is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue before the employer can take any action against you, including terminating your employment. Employers can only use E-Verify once you have accepted a job offer and completed the I-9 Form.</div>

Data Scientist, Journeyman

ImmunityBio, Inc.

<div>
 
 Company Overview
 
 
 
 ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient&rsquo;s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient&rsquo;s immune system and treat the host rather than just the disease.
 
 
 Why ImmunityBio?
 
 
 <ul>
 <li>
 ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
 </li>
 <li>
 Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
 </li>
 <li>
 Work with a collaborative team with the ability to work across different areas of the company.
 </li>
 <li>
 Ability to join a growing company with professional development opportunities.
 
 
 </li>
 </ul>
 
 Position Summary
 
 
 
 The Clinical Research Associate I 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.
 
 
 
 Essential Functions
 
 
 
 <ul>
 <li>
 Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
 </li>
 <li>
 Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
 </li>
 <li>
 Communicate scientific rationale for assigned studies to team members and clinical sites
 </li>
 <li>
 Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
 </li>
 <li>
 Create/edit, distribute and collect site feasibility questionnaires
 </li>
 <li>
 Oversee and support collection of essential documents during study start-up
 </li>
 <li>
 Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.
 </li>
 <li>
 Collect study and site metrics and maintain study trackers, as needed
 </li>
 <li>
 Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries
 </li>
 <li>
 Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits
 </li>
 <li>
 Partner with field CRAs and CTAs to resolve issues identified during site visits
 </li>
 <li>
 Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions
 </li>
 <li>
 Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
 </li>
 <li>
 Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor
 </li>
 <li>
 Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors
 </li>
 <li>
 Conduct remote monitoring tasks including reconciliation of site investigational product accountability
 </li>
 <li>
 Provide data listings and compile clinical study report documents to support medical writing activities
 </li>
 <li>
 Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
 </li>
 <li>
 Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate.
 </li>
 <li>
 Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
 
 
 </li>
 </ul>
 
 Education &amp; Experience
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in a clinical research, science, or health-related field with 2 years of experience in a clinical research setting; or a high school diploma with 3 years of experience in a clinical research setting required
 </li>
 <li>
 2 years of experience as a Clinical Research Coordinator, Clinical Trial Associate or In-House Clinical Research Associate strongly preferred
 
 
 </li>
 </ul>
 
 Knowledge, Skills, &amp; Abilities
 
 
 
 <ul>
 <li>
 Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
 </li>
 <li>
 Excellent written/oral communication skills
 </li>
 <li>
 Strong organizational and multi-tasking skills
 </li>
 <li>
 Maintain corporate confidentiality at all times
 </li>
 <li>
 Ability to set priorities and independent decision making
 </li>
 <li>
 Ability to work independently as well as in teams
 </li>
 <li>
 Strong oral and written communication skills
 </li>
 <li>
 Outgoing and confident demeanor
 </li>
 <li>
 Independent thinker and persuasive communicator
 </li>
 <li>
 Detail oriented, with solid organization and time management skills
 </li>
 <li>
 Completes projects with reliability and minimal guidance
 </li>
 <li>
 Knowledge of drug development process
 </li>
 <li>
 Computer literacy: EDC, eTMF, CTMS, etc.
 </li>
 <li>
 Working knowledge of ICH E6, and the Code of Federal Regulations
 
 
 </li>
 </ul>
 
 Working Environment / Physical Environment
 
 
 
 <ul>
 <li>
 This position works remotely with ability to work flexible hours for various time zones
 </li>
 <li>
 Must be able to travel up to 75% of the time based on study requirement.
 
 
 </li>
 </ul>
 This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate&rsquo;s qualifications, prior experience as well as geographic location.
 
 
 $103,900 (entry-level qualifications) to $114,300 (highly experienced) annually
 
 
 The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
 
 
 ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options
 
 
 <ul>
 <li>
 Health and Financial Wellness Programs
 </li>
 <li>
 Employer Assistance Program (EAP)
 </li>
 <li>
 Company Paid and Voluntary Life/AD&amp;D, Short-Term and Long-Term Disability
 </li>
 <li>
 Healthcare and Dependent Care Flexible Spending Accounts
 </li>
 <li>
 401(k) Retirement Plan with Company Match
 </li>
 <li>
 529 Education Savings Program
 </li>
 <li>
 Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
 </li>
 <li>
 Paid Time Off (PTO) includes: 11 Holidays
 </li>
 <li>
 Exempt Employees are eligible for Unlimited PTO
 </li>
 <li>
 Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
 </li>
 <li>
 We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
 
 
 </li>
 </ul>
 At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
</div>

Clinical Research Associate I, Field Monitor

Alto Neuroscience

<div>
 
 Primary Role
 
 
 
 The Clinical Research Associate (CRA) is responsible for the oversight of assigned investigative sites in accordance with all applicable protocols, project plans, Sponsor SOPs, GCP guidelines, and regulatory requirements from site initiation through site close out. The CRA assists the Clinical Trial Manager and/or Clinical Project Manager by managing their assigned clinical sites to ensure enrollment, timely review of data, identification of site issues, and prompt resolution of issues. The CRA is the primary liaison between the clinical investigator and the Sponsor to ensure the recruitment, enrollment, and site activities are executed on time, within budget, and with the highest quality data standards.
 
 
 
 What You'll Do
 
 
 
 <ul>
 <li>
 Perform site management and act as the primary liaison to the investigator and site staff ensuring consistent and effective communication related to enrollment status, issues and other relevant study information
 </li>
 <li>
 Conduct Site Evaluation, Site Initiation, Interim Monitoring, Close-out, and other study-specific visits including the completion of visit reports and follow-up letters after each visit
 </li>
 <li>
 Assist with the preparation of appropriate training materials and provide protocol and study related training including GCP and regulatory requirements to assigned sites
 </li>
 <li>
 Evaluate the quality and integrity of site practices to ensure GCP compliance and escalate any quality issues as appropriate
 </li>
 <li>
 Manage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
 </li>
 <li>
 Ensure the collection and maintenance of required essential documents and ensure these documents are filed in the Investigator Site File and Trial Master File
 </li>
 <li>
 Train site staff on proper preparation, handling, storage, and return/destruction of investigational product(s) and verify compliance during monitoring visits
 </li>
 <li>
 Develop a patient recruitment plan in conjunction with the site, address challenges and barriers to enrollment, and report the subject recruitment rate to the Clinical Project Manager
 </li>
 <li>
 Verify that written informed consent is obtained before each subject&rsquo;s participation in the trial
 </li>
 <li>
 Verify that source documents, other trial records, and CRFs are accurate, complete, and legible and that CRF entries reflect the source
 </li>
 <li>
 Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), Sponsor and the applicable regulatory requirement(s) Ensure deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements are documented and communicated appropriately and take appropriate action to prevent recurrence of the detected deviations
 </li>
 <li>
 Assist with the coordination and conduct of investigator and study meetings, including preparation and presentation of information
 </li>
 <li>
 Collaborate with team members in a mutually supportive and cooperative manner, as required to achieve study and project goals
 
 
 </li>
 </ul>
 
 LOCATION
 
 
 
 Remote
 
 
 
 Travel Requirements
 
 
 
 60% travel required
 
 
 (1-2 days per week)
 
 
 
 SALARY RANGE
 
 
 
 $80-125K Base Salary
 
 
 
 Depending On Qualifications And Experience Level
 
 
 
 
 QUALIFICATONS
 
 
 
 
 Required Skills
 
 
 
 <ul>
 <li>
 Experience monitoring clinical trials with rater-administered measures preferred
 </li>
 <li>
 Certified Clinical Research Associate (CCRA) credentialing is preferred
 </li>
 <li>
 Proactive in identifying areas of improvement to drive efficiency within Clinical Operations
 </li>
 <li>
 Knowledge of the clinical research discipline, GCP, and ICH-E6 is essential
 </li>
 <li>
 Excellent interpersonal skills required
 </li>
 <li>
 Proficiency with systems (CTMS, EDC, eTMF) and MS Office (Word, Excel, Outlook)
 </li>
 <li>
 The CRA must possess the ability to work closely with cross-functional colleagues within a small company, displaying innovative thinking, analytical thinking, a strong sense of responsibility, accountability, and integrity
 
 
 </li>
 </ul>
 
 Education And Experience
 
 
 
 <ul>
 <li>
 BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experience
 </li>
 <li>
 Minimum 2 years of experience, relevant CRO/biotech/pharmaceutical industry, including on-site or remote monitoring experience
 
 
 </li>
 </ul>
 
 WHY ALTO
 
 
 
 At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics.
 
 
 A lto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.
 
 
 - Remote
</div>

Clinical Research Associate

<div>
 
 Company Overview
 
 
 
 ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient&rsquo;s natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient&rsquo;s immune system and treat the host rather than just the disease.
 
 
 Why ImmunityBio?
 
 
 <ul>
 <li>
 ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
 </li>
 <li>
 Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
 </li>
 <li>
 Work with a collaborative team with the ability to work across different areas of the company.
 </li>
 <li>
 Ability to join a growing company with professional development opportunities.
 
 
 </li>
 </ul>
 
 Position Summary
 
 
 
 The Clinical Research Associate, In-House 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.
 
 
 
 Essential Functions
 
 
 
 <ul>
 <li>
 Review of study-related materials including site initiation training slides, site specific informed consent form templates, procedures and laboratory manuals and development/procurement of applicable appendix documents
 </li>
 <li>
 Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects, safety, data evaluation methods to support review of study-related materials
 </li>
 <li>
 Track and maintain ImmunityBio study personnel list and training records for assigned studies
 </li>
 <li>
 Communicate study rationale for assigned studies to study team members and clinical sites
 </li>
 <li>
 Support Clinical Trial Manager (CTM) and Clinical Program Manager (CPM) with triage of clinical site inquiries regarding protocol interpretation and eligibility requirements
 </li>
 <li>
 Create/edit site feasibility questionnaire template, track feasibility/start-up activities
 </li>
 <li>
 Create regulatory document templates, oversee and support collection of essential documents during site start-up
 </li>
 <li>
 Review non-investigational product (non-IP) supply list from the CTM for research sample processing and shipment, review non-IP supply orders forms and work with Supply Chain (SC) for distribution to clinical sites
 </li>
 <li>
 File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for study and country level documents and provide tracking and/or metrics throughout the study lifecycle as delegated by the CTM
 </li>
 <li>
 Communicate regularly with field Clinical Research Associates (CRAs) during site start-up and provide missing document list before the Site Initiation Visit and as needed for subsequent visits
 </li>
 <li>
 Partner with field CRAs and CTAs to resolve document issues identified during site visits
 </li>
 <li>
 Review investigational product (IP) metrics to ensure sites maintain sufficient quantities to properly conduct the trial as well as work with SC to ensure IP temperature monitoring excursions are documented and train or assist sites with corrective actions
 </li>
 <li>
 File documents to the Trial Master File (TMF) and maintain expected document lists (EDLs) for assigned site documents and provide tracking and/or metrics throughout the study lifecycle
 </li>
 <li>
 File documents to the TMF on behalf of functional groups that do not have access to the TMF as needed
 </li>
 <li>
 Perform content review and post approval review of documents filed to the TMF
 </li>
 <li>
 Provide approved study manuals and form templates to clinical sites in anticipation of Site Initiation Visit
 </li>
 <li>
 Support training of suppliers, investigators, and study coordinators on study requirements and provide guidance on site issues
 </li>
 <li>
 Conduct clinical specimen log review, track and coordinate shipment of specimens to the sponsor or contracted supplier
 </li>
 <li>
 Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted suppliers, create and manage site shipping accounts
 </li>
 <li>
 Support supplier oversight including working with supplier quality group for supplier qualification and new vendor request process with finance and accounting
 </li>
 <li>
 Conduct remote monitoring tasks including reconciliation of site investigational product accountability
 </li>
 <li>
 Audit Investigator/Site invoices for accuracy and reconcile invoices against the case report forms (CRFs) and budget for payment submission, perform invoice reconciliation at site close-out
 </li>
 <li>
 Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations and functional groups as needed. Request invoice approval from internal supplier designee(s).
 </li>
 <li>
 Work with accounting and finance to ensure activated clinical site record is added to the ERP System for site payment processing
 </li>
 <li>
 Provide data listings and compile clinical study report documents to support medical writing activities
 </li>
 <li>
 Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations
 </li>
 <li>
 Participate in clinical operations safety reporting activities including distribution to sites, tracking, IRB submission, TMF filing and completion of required form for updates to Safety Distribution System for site personnel or site status changes
 </li>
 <li>
 Submit clinical trial documentation to central IRB after initial submission by the CTM as needed
 </li>
 <li>
 Collaborate with other functional groups such as data management, pharmacovigilance, biostatistics etc. to ensure clinical trial activities are documented efficiently, compliant with regulations and standards, and aligned with project objectives
 </li>
 <li>
 Assist CTM with management of trial projects as delegated by the CTM
 </li>
 <li>
 Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities
 
 
 </li>
 </ul>
 
 Education &amp; Experience
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree with 4+ year experience as a Clinical Trials Associate (or 7+ years&rsquo; clinical research experience) required; or
 </li>
 <li>
 Associate&rsquo;s degree with 7+ years&rsquo; experience as a Clinical Trials Associate (or 10+ years clinical research experience) required
 
 
 </li>
 </ul>
 
 Knowledge, Skills, &amp; Abilities
 
 
 
 <ul>
 <li>
 Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
 </li>
 <li>
 Excellent written/oral communication skills
 </li>
 <li>
 Strong organizational and multi-tasking skills
 </li>
 <li>
 Maintain corporate confidentiality at all times
 </li>
 <li>
 Ability to set priorities and independent decision making
 </li>
 <li>
 Ability to work independently as well as in teams
 </li>
 <li>
 Strong oral and written communication skills
 </li>
 <li>
 Outgoing and confident demeanor
 </li>
 <li>
 Independent thinker and persuasive communicator
 </li>
 <li>
 Detail oriented, with solid organization and time management skills
 </li>
 <li>
 Completes projects with reliability and minimal guidance
 </li>
 <li>
 Knowledge of drug development process
 </li>
 <li>
 Computer literacy: EDC, eTMF, CTMS, etc.
 </li>
 <li>
 Working knowledge of ICH E6, and the Code of Federal Regulations
 
 
 </li>
 </ul>
 
 Working Environment / Physical Environment
 
 
 
 <ul>
 <li>
 This position works on site in El Segundo, CA or remotely depending on the geographic location of the candidate
 </li>
 <li>
 Regular work schedule is Monday &ndash; Friday, within standard business hours. Flexibility is available with manager approval.
 
 
 </li>
 </ul>
 This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate&rsquo;s qualifications, prior experience as well as geographic location.
 
 
 National Market (all markets unless identified as Premium)
 
 
 $82,000 (entry-level qualifications) to $90,200 (highly experienced) annually
 
 
 Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, &amp; Boston)
 
 
 $87,000 (entry-level qualifications) to $95,700 (highly experienced) annually
 
 
 The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
 
 
 ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options
 
 
 <ul>
 <li>
 Health and Financial Wellness Programs
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 Employer Assistance Program (EAP)
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 Company Paid and Voluntary Life/AD&amp;D, Short-Term and Long-Term Disability
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 Healthcare and Dependent Care Flexible Spending Accounts
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 401(k) Retirement Plan with Company Match
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 529 Education Savings Program
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 Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
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 Paid Time Off (PTO) includes: 11 Holidays
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 Exempt Employees are eligible for Unlimited PTO
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 Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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 We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
 
 
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 At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
</div>

Clinical Research Associate, In-House

Abridge

<div>
 
 About Abridge
 
 
 
 Abridge was founded in 2018 with the mission of powering deeper understanding in healthcare. Our AI-powered platform was purpose-built for medical conversations, improving clinical documentation efficiencies while enabling clinicians to focus on what matters most&mdash;their patients.
 
 
 Our enterprise-grade technology transforms patient-clinician conversations into structured clinical notes in real-time, with deep EMR integrations. Powered by Linked Evidence and our purpose-built, auditable AI, we are the only company that maps AI-generated summaries to ground truth, helping providers quickly trust and verify the output. As pioneers in generative AI for healthcare, we are setting the industry standards for the responsible deployment of AI across health systems.
 
 
 We are a growing team of practicing MDs, AI scientists, PhDs, creatives, technologists, and engineers working together to empower people and make care make more sense. We have offices located in the Mission District in San Francisco, the SoHo neighborhood of New York, and East Liberty in Pittsburgh.
 
 
 
 The Role
 
 
 
 As the Clinical Success Director - Nursing, you will be at the forefront of defining, launching, and growing our generative AI platform for nurses. Your work will directly contribute to improving the cognitive burden associated with clinical documentation. You will collaborate with clients, partners, product managers, designers, machine learners, and healthcare professionals to bring to life products that bridge the gap between clinical conversations and actionable data.
 
 
 
 *To be hired you must be based in the Mountain or Pacific time zone
 
 *
 
 
 
 What You&rsquo;ll Do
 
 
 
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 Evaluate new product offerings and provide subject matter expertise to our product teams.
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 Build and maintain relationships across customers, including onboarding users, listening to customer feedback, optimizing nursing workflows, and identifying opportunities for improved engagement and success.
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 Design and recruit a council of trusted nurse advisors to guide product strategy and roadmap.
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 Develop a use case-specific end-user survey and a set of success metrics to help communicate impact and value.
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 Evangelize product capabilities and direction to prospective customers by creating sales collateral, conducting product demos, training, and more.
 
 
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 What You&rsquo;ll Bring
 
 
 
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 5+ years of experience as an RN, preferably in the inpatient setting
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 Experience with electronic record systems (Epic is a definite plus)
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 Passion for deeply understanding nursing workflows and improving inefficiencies
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 Proven track record of leading successful initiatives from conception through launch
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 Ability to build relationships with different layers of an organization, from front-line staff to executives
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 Strong understanding of the healthcare industry, specifically clinical workflows and regulatory requirements
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 Experience working with cross-functional teams in a fast-paced, startup environment
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 This role requires 25% travel***
 
 
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 Why Work at Abridge?
 
 
 
 At Abridge, we&rsquo;re transforming healthcare delivery experiences with generative AI, enabling clinicians and patients to connect in deeper, more meaningful ways. Our mission is clear: to power deeper understanding in healthcare. We&rsquo;re driving real, lasting change, with millions of medical conversations processed each month.
 
 
 Joining Abridge means stepping into a fast-paced, high-growth startup where your contributions truly make a difference. Our culture requires extreme ownership&mdash;every employee has the ability to (and is expected to) make an impact on our customers and our business.
 
 
 Beyond individual impact, you will have the opportunity to work alongside a team of curious, high-achieving people in a supportive environment where success is shared, growth is constant, and feedback fuels progress. At Abridge, it&rsquo;s not just what we do&mdash;it&rsquo;s how we do it. Every decision is rooted in empathy, always prioritizing the needs of clinicians and patients.
 
 
 We&rsquo;re committed to supporting your growth, both professionally and personally. Whether it's flexible work hours, an inclusive culture, or ongoing learning opportunities, we are here to help you thrive and do the best work of your life.
 
 
 If you are ready to make a meaningful impact alongside passionate people who care deeply about what they do, Abridge is the place for you.
 
 
 
 How we take care of Abridgers:
 
 
 
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 Generous Time Off: 14 paid holidays, flexible PTO for salaried employees, and accrued time off for hourly employees
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 Comprehensive Health Plans: Medical, Dental, and Vision coverage for all full-time employees and their families.
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 Generous HSA Contribution: If you choose a High Deductible Health Plan, Abridge makes monthly contributions to your HSA.
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 Paid Parental Leave: Generous paid parental leave for all full-time employees.
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 Family Forming Benefits: Resources and financial support to help you build your family.
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 401(k) Matching: Contribution matching to help invest in your future.
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 Personal Device Allowance: Tax free funds for personal device usage.
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 Pre-tax Benefits: Access to Flexible Spending Accounts (FSA) and Commuter Benefits.
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 Lifestyle Wallet: Monthly contributions for fitness, professional development, coworking, and more.
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 Mental Health Support: Dedicated access to therapy and coaching to help you reach your goals.
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 Sabbatical Leave: Paid Sabbatical Leave after 5 years of employment.
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 Compensation and Equity: Competitive compensation and equity grants for full time employees.
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 ... and much more!
 
 
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 Equal Opportunity Employer
 
 
 
 Abridge is an equal opportunity employer and considers all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability.
 
 
 
 Staying safe - Protect yourself from recruitment fraud
 
 
 
 We are aware of individuals and entities fraudulently representing themselves as Abridge recruiters and/or hiring managers. Abridge will never ask for financial information or payment, or for personal information such as bank account number or social security number during the job application or interview process. Any emails from the Abridge recruiting team will come from an @abridge.com email address. You can learn more about how to protect yourself from these types of fraud by referring to this article. Please exercise caution and cease communications if something feels suspicious about your interactions.
 
 
 Compensation Range: $143,650 - $198,000
 
 
</div>

Clinical Success Director - Nursing

Cedars-Sinai

<div>
 
 Job Description
 
 
 
 Working under direct supervision, the Research Associate I performs a variety of routine experimental protocols and procedures to support the objectives of one or more laboratory research projects in a specific area of research. Assists in general laboratory activities, including maintenance of reagents and stocking of supplies. Files and monitors documents. Keeps accurate and detailed records of experiments and results. Assists in the operation of specialized equipment and machinery. Observes safety standards and procedures. The Research Assistant I will be able to perform routine cellular, micro- and molecular biology procedures including, but not limited to Western, Northern blot, DNA/RNA, PCR, protein extraction, cell culture, Immunohistochemistry, and staining. This position does not have supervisory responsibilities.
 
 
 
 Primary Duties And Responsibilities
 
 
 
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 Performs a variety of routine laboratory tasks and procedures.
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 Keeps accurate and detailed project records of experiments and results.
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 May assist with animal husbandry.
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 Maintains lab equipment and related records.
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 Transports, processes and logs samples.
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 Maintains computer database with relevant clinical information.
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 Performs lab maintenance duties, including glassware cleaning and sterilization.
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 Maintains stocks of general lab materials, and places orders for lab equipment and supplies.
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 Assists new students and fellows at the laboratory.
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 Assists in the operation of specialized equipment and machinery.
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 Observes and complies with safety standards and procedures.
 
 
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 Department-Specific Responsibilities
 
 
 
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 Assist with rodent surgeries and electrophysiological and behavioral recordings in models of neural injury/ stroke.
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 Support setup and refinement of new platforms for mouse motor behavior recordings and mouse stroke models.
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 Assist with intracranial recordings in mice and rats during stroke recovery, as well as EEG recordings for seizure monitoring.
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 Perform perfusion, histology, and tissue staining for stroke volume assessment and viral expression analysis.
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 Assist with electrophysiological data analysis, including spike sorting, behavioral kinematic analysis, and DeepLabCut-based automated pose estimation.
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 Serve as the lab's Controlled Substance (CS) designee, coordinating with Comparative Medicine to maintain CS inventory logs.
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 Assist with IACUC compliance activities and serve as the primary liaison with Comparative Medicine for routine inspections.
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 Represent the lab in Environmental Health &amp; Safety (EHS) matters, including monthly safety meetings.
 
 
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 </ul>
 
 
 
 Qualifications
 
 
 
 
 
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 Minimum Requirement: Bachelor&rsquo;s degree in a science-related field.
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 Preferred: Prior experience supporting rodent surgical procedures, electrophysiological and behavioral recording techniques, and laboratory compliance activities.
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</div>

Research Associate I, Gulati Lab

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