Clinical Trial Associate — Start-up & Study Operations

VIKING THERAPEUTICS INC

San Diego (CA)

On-site

USD 60,000 - 70,000

Full time

5 days ago
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Job summary

Viking Therapeutics, Inc. is seeking a Clinical Trial Associate to provide administrative support to the Clinical Operations Team across study start-up, maintenance, closure and vendor management, in alignment with GCP and SOPs.

The role requires a Bachelor’s degree and at least one year in clinical trials, with knowledge of FDA/ICH/GCP CFR guidelines. Proficiency in MS Office and strong organizational skills are essential.

Qualifications

  • Bachelor's degree in a related field required.
  • Minimum of one-year relevant clinical trial experience in pharma/biotech.
  • Prior CTA experience or knowledge of FDA/ICH/GCP CFR guidelines and regulatory requirements.

Responsibilities

  • Supports reviewing, formatting, and finalizing protocols and key study documents.
  • Provides administrative support with document reviews, follow-ups, and timelines.
  • Develops and maintains study tools and trackers (contact lists, vendor contracts, site visit reports).
  • Route and track approval forms for essential documents (e.g., ICFs, study plans).
  • Submit contracts and budgets to finance; request liability certificates; manage disclosures.
  • Collaborate with eTMF Owner to draft and finalize the eTMF Plan and EDLs.
  • Oversee TMF filing and reconciliation; ensure proper Site Essential Documents filling.
  • Participate in meetings and cross-functional initiatives; review monitoring reports.

Skills

Organizational skills
Communication skills
Administrative skills

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Viking Therapeutics, Inc. is seeking a Clinical Trial Associate to provide administrative support to the Clinical Operations Team across study start-up, maintenance, closure and vendor management, in alignment with GCP and SOPs.

The role requires a Bachelor’s degree and at least one year in clinical trials, with knowledge of FDA/ICH/GCP CFR guidelines. Proficiency in MS Office and strong organizational skills are essential.

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