Clinical Trials Associate

Role Summary

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

Responsibilities

• 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.

Qualifications

• Bachelor‚Äôs 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‚Äôs geographic location
• Regular work schedule is Monday ‚Äì Friday, within standard business hours. Flexibility is available with manager approval.