Associate Clinical Trial Manager

🕒 2 days ago

🏄 California – Remote

🏄 California – Remote

💵 $122k - $137k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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Erasca, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $100M Post-IPO Equity on 2022-12

Biotechnology • Pharmaceuticals • Science

Erasca, Inc. is a clinical-stage precision oncology company committed to eradicating cancer by targeting one of cancer's most commonly mutated pathways, the RAS/MAPK pathway. The company is dedicated to developing a modality-agnostic portfolio of therapeutic programs designed to thoroughly shut down the RAS/MAPK pathway, which affects millions of lives globally each year. Erasca is advancing a robust pipeline with the potential to transform cancer treatment and improve the lives of patients suffering from various types of cancer. With a focus on groundbreaking science in oncology, Erasca aims to bring new hope to patients and lead the way in precision oncology innovations.

📋 Description

• 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 for clinical studies and operational workflows. • Manage user accounts, permissions, roles and eTMF access. • Maintain TMF structure and index according to ICH-GCP and Erasca SOPs. • Review the CRO’s work filing, classifying, and indexing documents into the eTMF. • 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.

🎯 Requirements

• Preference for undergraduate degree in Biological Sciences or professions (pharmacy, medicine, nursing, or other allied health sciences) with a minimum of 1-2 years of relevant experience. • At least 1-2 years of experience in clinical operations in pharmaceutical company or CRO including trial set-up, monitoring, and close-out of US and non-US trials at all phases of pre-NDA clinical research (Phases 1-3). • 1-2 years experience in TMF/document management or clinical trial support. • Experience with eTMF systems (e.g. Trial Interactive eTMF, Veeva Vault). • Demonstrated track record of successfully supporting multiple projects, trials, and priorities. • Experience with managing study vendors (e.g., CRO, IRT/IXRS, central laboratories, eTMF/CTMS) preferred. • Practical knowledge and implementation of ICH-GCP guidelines and US and ex-US regulations. • Ability to work well with global, multi-disciplinary teams. • Must be a self-starter able to thrive in an entrepreneurial, fast paced, and dynamic work environment. • Must be organized with excellent oral and written communication skills. • Strong learning orientation, curiosity, and commitment to science and patients.

🏖️ Benefits

• Paid Time Off • Holiday and Sick Leave • Medical, Dental and Vision Plans • Short- and Long-Term Disability • Basic and Voluntary Life/AD&D Coverage • Flexible Spending Accounts (FSA, HSA, and Commute) • Critical Illness and Accident Coverage • Pet Insurance • Employee Assistance Program • 401(k) Plan with Erasca contribution • Opportunity to participate in an Employee Stock Purchase Program