Clinical Trial Operations Specialist

Regulatory Jobs; San Diego (CA); On-site; USD 60,000 - 70,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Clinical Trial Associate to support the Clinical Operations Team across trial start-up, maintenance, and closure phases in compliance with GCP, SOPs, and regulatory standards.

You will manage study documents, trackers, and approvals while coordinating with Regulatory Affairs and vendors. The ideal candidate has a Bachelor’s degree and at least one year of trial experience, with knowledge of FDA/ICH/GCP CFR guidelines and strong organizational skills.

Qualifications

• Bachelor’s degree in a related field is required.
• Minimum of one year of clinical trial experience in pharma/biotech.
• Experience as a CTA and knowledge of FDA/ICH/GCP CFR guidelines.

Responsibilities

• Support with reviewing, formatting, and finalizing protocols and study documents.
• Provide administrative support, update timelines, and track tasks.
• Develop and maintain study tools and trackers (contact lists, vendor contracts, site visit reports).
• Route and track essential approvals (ICFs, study plans, etc.).
• Submit study agreements and budgets; request insurance certificates as needed.
• Collaborate with Regulatory Affairs and draft eTMF plans and EDLS.

Skills

Organizational skills

Communication skills

Administrative skills

Multitasking

Education

Bachelor’s degree

Tools

MS Office

Excel

PowerPoint

Job description

Viking Therapeutics, Inc. is seeking a Clinical Trial Associate to support the Clinical Operations Team across trial start-up, maintenance, and closure phases in compliance with GCP, SOPs, and regulatory standards.

You will manage study documents, trackers, and approvals while coordinating with Regulatory Affairs and vendors. The ideal candidate has a Bachelor’s degree and at least one year of trial experience, with knowledge of FDA/ICH/GCP CFR guidelines and strong organizational skills.