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.
Gujarat :
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