Erasca, Inc.

Clinical Research

• Manage or assist in the management of large global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements.
• Support key study-related activities and deliverables.
• Support implementation of training programs ensuring relevant employees are trained as needed to ensure compliance with the protocol and other study-related documents.
• Track study progress and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking).
• Provide progress updates to relevant project teams and present a plan of action for resolution of issues (e.g., trial issues, investigator/study coordinator feedback, monitoring issues, patient enrollment issues).
• Maintain and support the eTMF and CTMS platform for clinical studies and operational workflows.
• Manage user accounts, permissions, roles and eTMF/CTMS access.
• Monitor eTMF/CTMS system performance, trouble shoot issues, and coordinate resolutions with vendor and/or study team members.
• Support eTMF/CTMS system upgrades, patches, testing, and validation activities.
• Maintain TMF structure and index according to ICH-GCP and Erasca SOPs.
• File, classify, and index documents into the eTMF.
• Perform ongoing review of trial TMF(s) to assure quality and compliance with relevant SOPs and ICH-GCP.
• Track, triage, and resolve missing or nonconformant documents. Collaborate with study team members to obtain required documents and ensure timely filing.
• Prepare and support regulatory and sponsor inspections/audits (document retrieval, audit trails, and corrective actions).
• May conduct (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with contracted monitors/CRO.
• Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Associate Clinical Trial Manager