Senior Clinical Research Associate, Field Monitor

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'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's immune system and treat the host rather than just the disease.

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 a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary

Senior Clinical Research Associate will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support.

Essential Functions

• 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
• Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc.
• Communicate scientific rationale for assigned studies to team members and clinical sites
• Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements
• Create / edit, distribute and collect site feasibility questionnaires
• Oversee and support collection of essential documents during study start-up
• Collect study and site metrics and maintain study trackers, as needed
• Participate in case report form (CRF) data review and review of source documents, work with sites to resolve data queries as needed
• Communicate regularly with field and in-house Clinical Research Associates (CRAs) to provide information before and after site visits
• Partner with field CRAs to resolve issues identified during site visits
• 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
• Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues
• Clinical specimen log review, coordinating shipment of specimens to the sponsor or contracted vendor
• Conduct remote monitoring tasks including reconciliation of site investigational product accountability, as needed
• Provide mentorship and training to newly hired research staff.
• Performs other duties as assigned.

Education & Experience

Bachelor's degree in a clinical research, science, or health-related field with 6 years of experience in a clinical research setting;

or a high school diploma with 8 years of experience in a clinical research setting

Minimum of 2 years' experience as a Clinical Research Associate II or higher required

Knowledge, Skills, & Abilities

• Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe
• Excellent written / oral communication skills as well as strong organizational and multi-tasking skills
• Strong organizational and multi-tasking skills
• Understand the job-specific system, processes as defined by the company's SOPs, and adhere to the requirements listed in those documents.

If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his / her supervisor or manager.

• Maintain corporate confidentiality at all times
• Ability to set priorities and independent decision making
• Ability to work independently as well as in teams
• Ability to discover issues, provides solutions and provides guidance to in-house team on how to address issues
• 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

• Must be able to travel up to 75% of the time based on study requirements
• On-site with ability to work flexible hours for various time zones

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's qualifications, prior experience as well as geographic location.

$120,000 (entry-level qualifications) to $138,000 (highly experienced)

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

• 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 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days 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.