[Hiring] Clinical Trials Associate @ImmunityBio, Inc.

Role Description

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

• 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 of 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.
• Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.

Qualifications

• Bachelor’s degree with 0-2 years of clinical research experience required; or
• High school diploma with 5+ years of clinical research experience required.

Requirements

• 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).

Benefits

• 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.