Instagram
youtube
Facebook

Clinical Trial Assistant

0-2 years
Not Disclosed
10 March 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trial Assistant

Location: San Francisco Bay Area
Employment Type: On-site, Full-time
Posted: 15 hours ago

Job Summary:

We are seeking a detail-oriented and highly organized Clinical Trial Assistant (CTA) to join our Clinical Operations team. The CTA will provide essential administrative and operational support to ensure the smooth execution of clinical trials, regulatory compliance, and project timelines.

Key Responsibilities:

Trial Coordination & Support:

  • Assist in the preparation, initiation, and monitoring of clinical trial activities.
  • Coordinate trial site setup, including processing contracts, ethics committee approvals, and investigator brochures.
  • Track and manage trial documentation to ensure compliance with regulatory standards.

Data & Document Management:

  • Maintain accurate trial records following Good Clinical Practice (GCP) and company SOPs.
  • Support collection, filing, and tracking of regulatory submissions, consent forms, and source documents.
  • Assist in preparing and submitting regulatory documentation for site initiation, amendments, and close-out activities.

Study Logistics & Scheduling:

  • Coordinate and schedule site visits, investigator meetings, and key study-related events.
  • Ensure study materials (e.g., investigational products, study supplies) are delivered on time.
  • Track study timelines, milestones, and deliverables to support project teams.

Communication & Liaison:

  • Serve as a point of contact between the clinical trial team, investigators, and external vendors.
  • Manage communication with sites, vendors, and internal stakeholders, ensuring smooth trial operations.

Compliance & Reporting:

  • Assist clinical trial managers with study reports and regulatory audits/inspections.
  • Maintain tracking systems for adverse events, protocol deviations, and other key study metrics.

Why Join?

  • Work in a fast-paced and impactful clinical research environment.
  • Gain hands-on experience in trial coordination and regulatory compliance.
  • Opportunity for career growth in clinical operations.