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clinical research associate, in-house

clinical researcher

clinical research associate

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

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, 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
 </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, In-House

<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

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
 
 
 
 <ul>
 <li>
 Performs a variety of routine laboratory tasks and procedures.
 </li>
 <li>
 Keeps accurate and detailed project records of experiments and results.
 </li>
 <li>
 May assist with animal husbandry.
 </li>
 <li>
 Maintains lab equipment and related records.
 </li>
 <li>
 Transports, processes and logs samples.
 </li>
 <li>
 Maintains computer database with relevant clinical information.
 </li>
 <li>
 Performs lab maintenance duties, including glassware cleaning and sterilization.
 </li>
 <li>
 Maintains stocks of general lab materials, and places orders for lab equipment and supplies.
 </li>
 <li>
 Assists new students and fellows at the laboratory.
 </li>
 <li>
 Assists in the operation of specialized equipment and machinery.
 </li>
 <li>
 Observes and complies with safety standards and procedures.
 
 
 </li>
 </ul>
 
 Department-Specific Responsibilities
 
 
 
 <ul>
 <li>
 Assist with rodent surgeries and electrophysiological and behavioral recordings in models of neural injury/ stroke.
 </li>
 <li>
 Support setup and refinement of new platforms for mouse motor behavior recordings and mouse stroke models.
 </li>
 <li>
 Assist with intracranial recordings in mice and rats during stroke recovery, as well as EEG recordings for seizure monitoring.
 </li>
 <li>
 Perform perfusion, histology, and tissue staining for stroke volume assessment and viral expression analysis.
 </li>
 <li>
 Assist with electrophysiological data analysis, including spike sorting, behavioral kinematic analysis, and DeepLabCut-based automated pose estimation.
 </li>
 <li>
 Serve as the lab's Controlled Substance (CS) designee, coordinating with Comparative Medicine to maintain CS inventory logs.
 </li>
 <li>
 Assist with IACUC compliance activities and serve as the primary liaison with Comparative Medicine for routine inspections.
 </li>
 <li>
 Represent the lab in Environmental Health &amp; Safety (EHS) matters, including monthly safety meetings.
 
 
 </li>
 </ul>
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Minimum Requirement: Bachelor&rsquo;s degree in a science-related field.
 </li>
 <li>
 Preferred: Prior experience supporting rodent surgical procedures, electrophysiological and behavioral recording techniques, and laboratory compliance activities.
 </li>
 </ul>
</div>

Research Associate I, Gulati Lab

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

Blue Shield of California

<div>
 
 Job Description
 
 
 
 
 Your Role
 
 
 
 The Federal Employee Program (FEP) team performs integrated case management (CM) and disease management (DM) activities demonstrating clinical judgment and independent analysis, collaborating with members and those involved with members&rsquo; care including clinical nurses and treating physicians. The Triage Registered Nurse Case Manager will report to the FEP Care Manager Department Manager. In this role you will determine, develop, and implement a plan of care based on accurate and comprehensive assessment of the members&rsquo; needs.
 
 
 Our leadership model is about developing great leaders at all levels and creating opportunities for our people to grow &ndash; personally, professionally, and financially. We are looking for leaders that are energized by creative and critical thinking, building and sustaining high-performing teams, getting results the right way, and fostering continuous learning.
 
 
 
 Working hours for this role: Monday-Thursday, 10:30am-7:00pm; Friday- 9:30am-6:00pm
 
 
 
 
 In the future there could be Saturday shift hours.
 
 
 
 
 Responsibilities
 
 
 
 
 Your Work
 
 
 
 In this role, you will:
 
 
 <ul>
 <li>
 Conduct provider searches and assists members in accessing medically necessary services within the access network
 </li>
 <li>
 Triage referrals coming from the 24-hours Nurse Line to ensure members see providers in timely fashion and receive necessary education on their health conditions
 </li>
 <li>
 Work with providers and other internal departments to initiate the Letter of Agreement (LOA) and Exception process
 </li>
 <li>
 Outreach to members with HEDIS Care Gaps to assist with closure
 </li>
 <li>
 Research and design treatment/care plans to promote quality of care, cost effective health care services based on medical necessity complying with contract for each appropriate plan type
 </li>
 <li>
 Provide Referrals to Quality Management (QM), Disease Management (DM) and Appeals and Grievance department (AGD)
 </li>
 <li>
 Recognize the client&rsquo;s right to self-determination as it relates to the ethical principle of autonomy, including the client/family's right to make informed choices that may not promote the best outcomes, as determined by the healthcare team
 </li>
 <li>
 Design appropriate and fiscally responsible plan of care with targeted interventions that enhance quality, access and cost-effective outcomes
 </li>
 <li>
 Initiate and implement appropriate modifications in plan of care to adapt to changes occurring over time and through various settings
 </li>
 <li>
 Applies detailed knowledge of FEP PPO and Blue Shield of California's (BSC) established medical/departmental policies, clinical practice guidelines, community resources, contracting and community care standards to each case
 </li>
 <li>
 Performs effective discharge planning and collaborates with member support system and health care professionals involved in the continuum of care
 </li>
 <li>
 Coordinates Care for Lower Level of Care coordination such as Skilled Nursing Facility, Home Health, Home Infusion, Rehab, and other community program as appropriate
 </li>
 <li>
 Provides disease management education on core chronic conditions (Diabetes, Heart Failure, COPD, Asthma and Coronary Artery Disease)
 </li>
 <li>
 Determines, develops and implements a plan of care based on accurate and comprehensive assessment of the member's needs related to behavioral health
 </li>
 <li>
 Must be able to sit for extended periods of time and read information on one computer screen and apply that information on a second computer screen to complete documentation
 
 
 </li>
 </ul>
 
 Qualifications
 
 
 
 
 Your Knowledge and Experience
 
 
 
 <ul>
 <li>
 Requires a current CA RN License
 </li>
 <li>
 Certified Case Manager (CCM) Certification or is in process of completing certification when eligible based on CCM application requirements
 </li>
 <li>
 Requires at least 5 years of prior experience in nursing, healthcare or related field
 </li>
 <li>
 Bachelor of Science in Nursing or advanced degree preferred
 </li>
 <li>
 Comprehensive knowledge of case management, discharge planning, utilization management, disease management and community resources
 </li>
 <li>
 Able to operate PC-based software programs including proficiency in Word and Excel.
 </li>
 <li>
 Strong clinical documentation skills, independent problem identification and resolution skills
 </li>
 <li>
 Strong supervisory, communication, abstracting skills with strong verbal and written communication skills and negotiation skills
 </li>
 <li>
 Competent understanding of NCQA and federal regulatory requirements.
 </li>
 <li>
 Knowledge of coordination of care, prior authorization, level of care and length of stay criteria sets desirable
 </li>
 <li>
 Demonstrates professional judgment, and critical thinking, to promote the delivery of quality, cost-effective care. This judgment is based on medical necessity including intensity of service and severity of illness within contracted benefits and appropriate level of care
 </li>
 <li>
 Demonstrate leadership, project management and program evaluation skills and ability to interact with all levels including senior management and influence decision-making
 
 
 </li>
 </ul>
 
 Hybrid Virtual Work
 
 
 
 This role allows employees to work virtually full-time, however employees will be expected to come into the office based on business needs.
 
 
 
 About The Team
 
 
 
 
 About Blue Shield of California
 
 
 
 As of January 2025, Blue Shield of California became a subsidiary of Ascendiun. Ascendiun is a nonprofit corporate entity that is the parent to a family of organizations including Blue Shield of California and its subsidiary, Blue Shield of California Promise Health Plan; Altais, a clinical services company; and Stellarus, a company designed to scale healthcare solutions. Together, these organizations are referred to as the Ascendiun Family of Companies.
 
 
 At Blue Shield of California, our mission is to create a healthcare system worthy of our family and friends and sustainably affordable. We are transforming health care in a way that genuinely serves our nonprofit mission by lowering costs, improving quality, and enhancing the member and physician experience.
 
 
 To achieve our mission, we foster an environment where all employees can thrive and contribute fully to address the needs of the various communities we serve. We are committed to creating and maintaining a supportive workplace that upholds our values and advances our goals.
 
 
 Blue Shield is a U.S. News Best Company to work for, a Deloitte U.S. Best Managed Company and a Top 100 Inspiring Workplace. We were recognized by Fair360 as a Top Regional Company, and one of the 50 most community-minded companies in the United States by Points of Light. Here at Blue Shield, we strive to make a positive change across our industry and communities &ndash; join us!
 
 
 
 Our Values:
 
 
 
 <ul>
 <li>
 Honest. We hold ourselves to the highest ethical and integrity standards. We build trust by doing what we say we're going to do and by acknowledging and correcting where we fall short.
 </li>
 <li>
 Human. We strive to listen and communicate effectively, showing empathy by understanding others' perspectives.
 </li>
 <li>
 Courageous. We stand up for what we believe in and are committed to the hard work necessary to achieve our ambitious goals.
 
 
 </li>
 </ul>
 
 Our Workplace Model
 
 
 
 We believe in fostering a workplace environment that balances purposeful in-person collaboration with flexibility - providing clear expectations while respecting the diverse needs of our workforce. Our workplace model is designed around intentional in-person interaction, collaboration, connection, creativity and flexibility:
 
 
 <ul>
 <li>
 For most teams, this means coming into the office two days per week.
 </li>
 <li>
 Employees living more than 50 miles from an office location, out of state employees, and employees in certain member-facing roles should work with their manager to determine in-office time based on business need.
 </li>
 <li>
 For employees with medical conditions that may impact their ability to work in-office, we are committed to engaging in an interactive process and providing reasonable accommodations to ensure their work environment is conducive to their success and well-being.
 
 
 </li>
 </ul>
 The Company reserves the right to require more presence in the office based on business needs, and requirements are subject to change with periodic reviews.
 
 
 
 Physical Requirements:
 
 
 
 Office Environment - roles involving part to full time schedule in Office Environment. Based in our physical offices and work from home office/deskwork - Activity level: Sedentary, frequency most of work day.
 
 
 Please click here for further physical requirement detail.
 
 
 
 Equal Employment Opportunity:
 
 
 
 External hires must pass a background check/drug screen. Qualified applicants with arrest records and/or conviction records will be considered for employment in a manner consistent with Federal, State and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regards to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran status or disability status and any other classification protected by Federal, State and local laws.
</div>

RN - Complex Care Coordination Triage Case Manager, Sr.

Manhattan Institute

<div>
 
 
 Researcher &ndash;
 
 City Journal
 
 
 
 
 
 
 
 Manhattan Institute for Policy Research (MI) is a community of scholars, journalists, activists, and civic leaders who are united by a shared commitment to advancing economic opportunity, individual liberty, and the rule of law in America and its great cities. We are seeking a like-minded researcher who will support a new team focused on misgovernance and public accountability in California.
 
 
 
 
 
 The team will operate through
 
 City Journal
 
 , MI&rsquo;s magazine of urban affairs, and be helmed by Manhattan Institute Senior Fellow and investigative journalist Christopher F. Rufo. It will focus on issues of waste, fraud, abuse in the Golden State, working to hold public actors accountable and preserve the public trust. The researcher will support a team of reporters, being the deep-dive backstop their work.
 
 
 
 
 
 A successful candidate will be able to research across a number of domains, including public records and quantitative analysis. A good researcher should have familiarity with records requests, know where to dig up Census figures or campaign contributions, and be able to turn around a handy visualization quickly. In general, this role is the team&rsquo;s Swiss army knife, offering the ability to find and aggregate large quantities of information quickly.
 
 
 
 
 
 This is an &ldquo;impact journalism&rdquo; role, with the goal of not only reporting the facts, but making real and immediate change. The researcher should see him or herself as part of that project, and be eager to contribute.
 
 
 
 
 
 
 Required qualifications
 
 
 <ul>
 <li>
 California-based. Experience doing research, public policy, or government affairs work in the state is a plus.
 </li>
 <li>
 Three-plus years of experience in a research-related role.
 </li>
 <li>
 Competency with public records, including CPRA requests and publicly available data in California.
 </li>
 <li>
 Skills with quantitative analysis (R, Python, Stata, etc.) and visualization.
 </li>
 <li>
 Dogged commitment to accuracy.
 </li>
 <li>
 Significant familiarity with the work of Rufo,
 
 CJ
 
 , and MI, and a desire to work in support of MI&rsquo;s mission.
 </li>
 <li>
 Spanish-language fluency a significant plus,
 
 but not required
 
 .
 </li>
 </ul>
 
 
 
 
 Candidates will be expected to be based in California, or relocate if hired.
 
 
 
 
 
 
 Benefits
 
 
 
 MI offers generous benefits, including a hybrid work environment, four weeks paid vacation, a Flexible Fridays program, paid paternity/maternity leave, medical and dental coverage, medical and dependent care FSA, mental health benefits, remote medicine, paid company cell phone, life insurance, and a 401(k) with a company-funded match. MI staff also benefit from the opportunity to collaborate and socialize with prominent scholars in our policy space.
 
 
 
 
 
 The salary range for this position is
 
 $75,000 to $200,000
 
 /year. The salary offered to a candidate will depend on skills, experience, and education.
 
</div>

Researcher – City Journal

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