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Clinical Trial Assistant Ii - Clinical Operations Process And Systems

1-3 years
Not Disclosed
10 April 28, 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

Job Title: Clinical Trial Assistant II - Clinical Operations Process and Systems
Location: Redwood City, CA
Employment Type: Full-time


Company Overview:

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to treat RAS-addicted cancers. With a strong pipeline of RAS(ON) Inhibitors and RAS Companion Inhibitors, the company is committed to improving patient outcomes by tackling oncogenic variants of RAS proteins. As a new member of the Revolution Medicines team, you will contribute to cutting-edge research in the fight against cancer.


Position Summary:

As the Clinical Trial Assistant II (CTA II), Clinical Operations Process and Systems, you will play a key role in supporting the management of Clinical Operations processes and systems. Your work will help ensure the execution of clinical trials is efficient, high-quality, and compliant with regulatory standards.


Key Responsibilities:

  • Process & System Support: Assist with the development, tracking, and management of central Clinical Operations activities. Contribute to the development of SOPs and standard processes for clinical trials.

  • Document Management: Assist with the creation, review, and distribution of clinical study documents and templates (e.g., study plans, training materials, study guides, etc.).

  • Clinical Systems: Support Clinical Operations Systems activities such as maintaining data in the Learning Management System (LMS), CTMS, CRM, and eTMF.

  • System Setup & Maintenance: Assist with the setup of new clinical systems (e.g., eTMF, CTMS) and maintain existing systems. Work with CROs or vendors to resolve discrepancies in the eTMF.

  • Support for Inspections: Assist with internal gap assessments, inspections, and ensuring inspection readiness.

  • Study Support: Track study-specific information, prepare meeting materials, and assist with study team activities such as sample management and site coordination.

  • Cross-functional Coordination: Liaise with vendors, study sites, and cross-functional teams to ensure smooth clinical trial operations.


Qualifications:

  • Education: RN or Bachelor’s degree in biological sciences or a health-related field preferred.

  • Experience: 1-3 years of relevant experience in Clinical Operations within the pharmaceutical or biotech industry.

  • Knowledge: Familiarity with GCP and ICH guidelines. Knowledge of clinical operations systems (e.g., CTMS, eTMF) is preferred.

  • Skills:

    • Proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint).

    • MS Project and/or Smartsheet experience a plus.

    • Strong attention to detail and excellent communication skills.

    • Experience with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS) is advantageous.

  • Preferred: Oncology experience is a plus.


Compensation and Benefits:

  • Salary: $75,000 - $90,000 annually, depending on experience.

  • Total Rewards: Competitive cash compensation, equity awards, robust benefits package, and significant learning and development opportunities.