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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