Clinical Trials Associate

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 1+ years of clinical research experience; or 5+ years of clinical research experience without a Bachelor’s degree

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

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.

$67,000 (entry-level qualifications) to $78,000 (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.
30+ days ago