Clinical Trial Operations Specialist

Viking Therapeutics, Inc.; San Diego (CA); Presencial; USD 60.000 - 70.000; Jornada completa

Descripción de la vacante

Viking Therapeutics, Inc. is seeking a Clinical Trial Associate (CTA) to provide administrative support across the full spectrum of clinical trial activities.

The role ensures compliance with GCP/SOPs and assists in study startup, maintenance, and closure, including document review, tracking, and regulatory submissions. The ideal candidate has a bachelor’s degree and at least one year of relevant CTA experience, with knowledge of FDA/ICH/GCP CFR guidelines and strong MS Office skills.

Formación

• Bachelor’s degree in a related or similar field.
• Minimum of one-year relevant clinical trial experience in the pharmaceutical and/or biotechnology industry.
• Prior experience as a CTA and/or knowledge of FDA, ICH, GCP, CFR guidelines, regulatory requirements, and clinical trials operations.

Responsabilidades

• Support review, formatting, and finalizing protocols and key study documents.
• Provide administrative support with document review, tracking, and timelines.
• Develop and maintain study tools and trackers (contacts, vendor contracts, site visits).
• Route and track approvals for essential study documents (ICF, study plans).
• Submit study agreements and budgets; request country-level insurance certificates.
• Coordinate with Regulatory Affairs and eTMF activities.
• Oversee TMF filing and ensure site documents are properly filed.
• Assist in study startup, maintenance, and closeout document review.
• Participate in meetings and collaborative efforts (protocols, CRO selection).
• QC study documents and support creation of study templates and materials.

Conocimientos

Organizational skills

Communication skills

Multitasking

Independent work

Educación

Bachelor’s degree

Herramientas

MS Office

Descripción del empleo

Viking Therapeutics, Inc. is seeking a Clinical Trial Associate (CTA) to provide administrative support across the full spectrum of clinical trial activities.

The role ensures compliance with GCP/SOPs and assists in study startup, maintenance, and closure, including document review, tracking, and regulatory submissions. The ideal candidate has a bachelor’s degree and at least one year of relevant CTA experience, with knowledge of FDA/ICH/GCP CFR guidelines and strong MS Office skills.