Clinical Trials Associate
ImmunityBio, Inc.
5 hours ago
Remote friendly (California, United States)
United States
Clinical Research and Development
Position Summary
Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies.
Essential Functions / Responsibilities
- Support the Clinical Operations teams in completing required tasks to meet trial, departmental, and project goals.
- Maintain knowledge of ICH GCP, applicable 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/site level documents) including preparation for audits, final reconciliation, and archival.
- Review clinical trial documents for compliance with Good Documentation Practices (GDocP); file and track study documents.
- Determine and manage materials/resources needed to conduct the trial (acquisition and distribution).
- Audit Investigator/Site invoices for accuracy; reconcile against CRFs and budget for payment submission.
- Gather central IRB report information, submit to the central IRB portal, and track submissions through approval.
- Facilitate collection/review of required study documents during site start-up.
- Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements).
- Route study documents for validated digital signatures.
- Submit purchase requisitions via ERP (Clinical Operations) and request invoice approval from internal supplier designee.
- Support clinical operations safety reporting: distribute, file, and track safety reports and IRB submissions.
- Coordinate team meetings, including agendas and minutes.
- Perform ad-hoc/cross-functional duties and/or projects as assigned.
Education & Experience (Required)
- Bachelor’s degree with 0–2 years of clinical research experience; OR
- High school diploma with 5+ years of clinical research experience.
Knowledge, Skills & Abilities (Required/Preferred)
- Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe.
- Excellent written/oral communication; strong organizational and multi-tasking skills.
- Maintain corporate confidentiality.
- Detail-oriented with strong organization and time management.
- Working knowledge of good documentation practices (GDP).
Benefits (as listed)
- Medical, Dental and Vision plan options; Health and Financial Wellness Programs; Employer Assistance Program (EAP)
- Company paid/voluntary life/AD&D, short-/long-term disability; healthcare and dependent care flexible spending accounts
- 401(k) with company match; 529 education savings program
- Paid Time Off (PTO) including 11 holidays (Unlimited PTO for exempt; Non-exempt: vacation days and health/personal/cultural days as listed).
Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies.
Essential Functions / Responsibilities
- Support the Clinical Operations teams in completing required tasks to meet trial, departmental, and project goals.
- Maintain knowledge of ICH GCP, applicable 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/site level documents) including preparation for audits, final reconciliation, and archival.
- Review clinical trial documents for compliance with Good Documentation Practices (GDocP); file and track study documents.
- Determine and manage materials/resources needed to conduct the trial (acquisition and distribution).
- Audit Investigator/Site invoices for accuracy; reconcile against CRFs and budget for payment submission.
- Gather central IRB report information, submit to the central IRB portal, and track submissions through approval.
- Facilitate collection/review of required study documents during site start-up.
- Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements).
- Route study documents for validated digital signatures.
- Submit purchase requisitions via ERP (Clinical Operations) and request invoice approval from internal supplier designee.
- Support clinical operations safety reporting: distribute, file, and track safety reports and IRB submissions.
- Coordinate team meetings, including agendas and minutes.
- Perform ad-hoc/cross-functional duties and/or projects as assigned.
Education & Experience (Required)
- Bachelor’s degree with 0–2 years of clinical research experience; OR
- High school diploma with 5+ years of clinical research experience.
Knowledge, Skills & Abilities (Required/Preferred)
- Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe.
- Excellent written/oral communication; strong organizational and multi-tasking skills.
- Maintain corporate confidentiality.
- Detail-oriented with strong organization and time management.
- Working knowledge of good documentation practices (GDP).
Benefits (as listed)
- Medical, Dental and Vision plan options; Health and Financial Wellness Programs; Employer Assistance Program (EAP)
- Company paid/voluntary life/AD&D, short-/long-term disability; healthcare and dependent care flexible spending accounts
- 401(k) with company match; 529 education savings program
- Paid Time Off (PTO) including 11 holidays (Unlimited PTO for exempt; Non-exempt: vacation days and health/personal/cultural days as listed).