Clinical Trial Operations Specialist

4 weeks ago

Redwood City, California, United States Revolution Medicines Full time
Revolution Medicines Clinical Operations Process and Systems Role

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. Our R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:
This is a unique opportunity for an entry-level Clinical Operations Professional. As the Clinical Trial Assistant II, Clinical Operations Process and Systems, you will be responsible for acting as an integral member of the Clinical Operations team and will be tasked to support the management of Clinical Operations processes and systems, in support of execution of RevMed's clinical trials.

  • Adhere to Clinical Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines
  • Under guidance of manager, assist with the development, tracking and management of central Clinical Operations activities.
  • Assist with development of standard processes, tracking and documentation to facilitate efficient and high-quality Clinical Operations processes across clinical studies.
  • Assist with Clinical Operations Systems activities, such as maintenance of information in the Learning Management System (LMS), Clinical Trial Management System (CTMS), Medical Client Relationship Management (CRM) system or electronic Trial Master File (eTMF).
  • May support the selection and set up of new clinical systems (e.g., eTMF, CTMS).
  • Assist in the development, review, distribution, and archiving of study documents and reports (e.g., essential documents, plans, training materials, study guides, manuals, etc.).
  • May assist with set-up and maintenance of clinical study eTMF(s), if applicable, and work with the CRO or vendor to audit and resolve discrepancies.
  • Assist study teams with sample management, reconciliation and generate trial progress tracking system.
  • May liaise with Clinical Supply and other cross functional teams with processing shipments, returns, and assist with in-house drug, specimen, and ancillary supply reconciliation.
  • Provide support to address existing and potential gaps in the eTMF.
  • Support Clinical Operations during internal gap assessments and during inspections.
  • Support inspection readiness.
  • Track and prepare study-specific information utilizing databases, trackers, and other study tools.
  • Assist in the preparation of meeting materials, including scheduling, developing agendas, and minute-taking for internal Clinical Operations team meetings.
  • May conduct other activities to support study teams, such as gathering investigator and site information to support study start-up, maintenance, and close-out activities, contacting investigator sites to provide study specific information, working with cross-functional study teams and vendors to assist in the coordination of clinical trial activities.
  • May serve as the point of contact for vendors or study sites, study monitors for clinical supplies or document collection.
  • Support other clinical operations activities as appropriate.

Required Skills, Experience and Education:
  • RN or bachelor's degree in biological sciences or health-related field desired.
  • 0-1 years (CTA I)/1-3 years (CTA II) relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.
  • Has knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guideline
  • Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
  • Excellent written and verbal communication and interpersonal skills.
  • Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
  • Travel may be required (~10%).

Preferred Skills, Experience and Education:
  • Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
  • Oncology experience preferred.
  • Attention to detail.

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