Clinical Trials Associate

Role Summary

Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies. Supports Clinical Operations teams in meeting trial, departmental and project goals while maintaining regulatory compliance and robust study documentation. This role may be on-site in El Segundo, CA or remote depending on geographic location.

Responsibilities

• Support the Clinical Operations teams in the completion of all required tasks to meet trial, departmental and project goals.
• Maintain knowledge of ICH GCP, applicable regulations, relevant SOPs, and internal tracking systems.
• Collaborate with the 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 and site level documents) including preparation for audits, reconciliation and archival.
• Review clinical trial documents to determine compliance with Good Documentation Practices (GDP); 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 against case report forms (CRFs) and budget for payment submission.
• Gather central IRB report information, submit to the central IRB portal and track IRB submissions from initiation through approval.
• Facilitate collection and review of required study documents during site start-up.
• Contact clinical sites for requests (e.g., enrollment updates, missing documentation, meeting arrangements).
• Route study documents to appropriate personnel for validated digital signatures.
• Submit purchase requisitions to ERP for Clinical Operations as needed and request invoice approvals 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.
• Performs other duties and projects as needed.

Education

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

Skills

• Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe.
• Excellent written and verbal communication; strong organizational and multi-tasking skills.
• Maintain corporate confidentiality at all times.
• Detail oriented with solid organization and time management skills.
• Working knowledge of good documentation practices (GDP).

Additional Requirements

• Working environment: on site in El Segundo, CA or remotely depending on geographic location.
• Schedule: Regular Monday–Friday, standard business hours with flexibility available with manager approval.