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Clinical Research Associate

Company: ImmunityBio
Location: Las Vegas
Posted on: September 10, 2023

Job Description:

ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company's immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term "immunological memory." Why ImmunityBio? * 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. * Opportunity to join an early-stage public biopharmaceutical company with a headquarters in Southern California. * Work with a collaborative team with the ability to work across different areas at the company. * Ability to join a growing company with development opportunities. Position Summary The position is responsible for assisting the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administrative and project tracking support. Essential Functions

  • Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
  • Assist with drafting and updating study-related training materials and documents including: site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals
  • Understand medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
  • Able to communicate scientific rationale for assigned studies
  • Provide guidance to sites including protocol interpretation and eligibility requirements
  • Create/edit, distribute and collect site feasibility questionnaires
  • Assist with collecting and tracking study and site metrics and maintaining study trackers, as needed
  • Conduct site visits including (but not limited to) site qualification visit, site initiation visits, interim montoring visits, study close-out visits.
  • Monitor, review, and collect regulatory documentation throughout the conduct of the study.
  • Assist with case report form (CRF) data review, work with sites to resolve data queries as needed
  • Assist field Clinical Research Associates (CRAs) with resolution of issues identified during visits
  • Work with Supply Chain to resolve investigational product (IP) temperature monitoring excursions and train or assist sites with corrective actions
  • Work with Supply Chain to ensure sites maintain sufficient IP to properly conduct the trial
  • Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues as needed
  • Clinical specimen log review, coordinating shipment of specimens to the sponsor or contracted vendor
  • Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors
  • Conduct remote monitoring tasks including reconciliation of site investigational product accountability, as needed
  • Provide data listings, compile clinical study report documents as needed to support to medical writing
  • To assist in the production of slides, overheads, etc., as needed for a project, departmental, sponsor and/or business development presentations
  • Develop strong site relationships with continuity throughout the study duration to ensure site compliance with the protocol.
  • Provide support to the clinical team, as needed
  • Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate
  • Perform other duties as assigned Education & Experience
    • BA/BS degree
    • 0-2 years' experience as a Clinical Trial Assistant (or 1+ years' experience as a Clinical Research Associate) (or 5+ years' clinical research experience);
    • Excellent written/oral communication skills as well as strong organizational and multi-tasking skills Knowledge, Skills, & Abilities
      • Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
      • Excellent written/oral communication skills
      • Strong organizational and multi-tasking skills
      • Maintain corporate confidentiality at all times
      • Ability to set priorities and independent decision making
      • Ability to work independently as well as in teams
      • Strong oral and written communication skills
      • Outgoing and confident demeanor
      • Independent thinker and persuasive communicator
      • Detail oriented, with solid organization and time management skills
      • Completes projects with reliability and minimal guidance
      • Knowledge of drug development process
      • Computer literacy: EDC, eTMF, CTMS, etc.
      • Working knowledge of ICH E6, and the Code of Federal Regulations Working Environment / Physical Environment
        • Travel Requirements: Up to 75% based on study requirements
        • Remote with occasional work in office if local; or can be fully remote if not local *All hires are based upon completion and passage of a background check. This position is eligible for a discretionary bonus and equity award. The pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $95,000(entry-level qualifications) to $115,000(highly experienced) 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 * Health and Financial Wellness Programs * Employer Assistance Program (EAP) * Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability * Healthcare and Dependent Care Flexible Spending Accounts * 401(k) Retirement Plan with Company Match * 529 Education Savings Program * Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks * Paid Time Off (PTO) includes: 11 Holidays * Exempt Employees are eligible for Unlimited PTO * Non-Exempt Employees are eligible for 15 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and and 1 Cultural Day* We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. 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. ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

Keywords: ImmunityBio, Las Vegas , Clinical Research Associate, Healthcare , Las Vegas, Nevada

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