Clinical Trials Associate

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

Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies.

Essential Functions

Support the Clinical Operations teams in the completion of all required tasks to meet trial, departmental and project goals.

Maintain, share and champion a thorough knowledge ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems.

Collaborate with Clinical Trials Manager (CTM) and Clinical Research Associates (CRAs) to resolve clinical trial documentation issues.

Establish, organize and maintain clinical study documentation (e.g. Trial Master File, study level and site level documents, etc.) including preparation for internal / external audits, final reconciliation and archival.

Review clinical trial documents to determine compliance with Good Documentation Practices (GDocP), file and track study documents.

Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution.

Audit Investigator / Site invoices for accuracy, and reconcile invoices against the case report forms (CRFs) and budget for payment submission.

Gather central IRB report information, submit the report to the central IRB portal and track the IRB submissions from beginning through approval.

Facilitate the collection and review of required study documents during site start-up

Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.)

Route study documents to the appropriate personnel for validated digital signatures

Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed. Request invoice approval from internal supplier designee.

Participate in clinical operations safety reporting activities; distribute, file and track safety reports and IRB submissions.

Facilitate clinical operations team meeting coordination, agenda preparation and meeting minutes preparation

Performs other duties and projects as needed.

Education & Experience

Bachelor's degree with 0-2 years of clinical research experience required; or

High school diploma with 5+ years of clinical research experience 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

Maintain corporate confidentiality at all times.

Strong oral and written communication skills

Detail oriented, with solid organization and time management skills

Working knowledge of good documentation practices (GDP)

Working Environment / Physical Environment

This position works on site in El Segundo, CA or remotely depending on the candidate's geographic location

Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.

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.

National Market (all markets unless identified as Premium)

$69,100 (entry-level qualifications) to $76,000 (highly experienced) annually

Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)

$72,800 (entry-level qualifications) to $80,000 (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

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.