ALX Oncology Inc.·South San Francisco, California
Supports clinical operations by managing the Trial Master File (TMF), coordinating site activation, and tracking study documents. Collaborates with CROs and internal teams to ensure regulatory compliance and efficient trial execution.
A Clinical Trial Associate (CTA) supports clinical operations by supporting and progressively owning key study execution activities including startup,Trial Master Files (TMF) management, tracking study documents, assisting with site activation, and managing trial reports and supplies.
They ensure compliance with ICH/GCP regulations and internal SOPs while proactively identifying gaps, escalating risks, and supporting inspection readiness.
Additional responsibilities include study coordination, vendor communication, and data tracking.
Additional Responsibilities
Support Clinical Trial Manager (CTM), Study lead and Study Management Team (SMT) in study start up and executional activities
Site Support: Support site activation, ethical submissions, and track site-level documents (e.g., informed consent forms). Assist in coordination of site onboarding and ensure completeness of site essential documentation
Vendor/Supply Management: Track and ship study-related materials and investigational products (IP). Support oversight of CRO and vendor deliverables, ensuring timelines and documentation expectations are met. Identify potential risks and proactively resolve issues with vendors. Assist in review of vendor management and other study plans. Tracking and requesting site access from vendors.
Study Tracking: Update trackers for enrollment, site monitoring, and data queries. Support maintenance of CTMS and study level tracking tools to ensure data accuracy and alignment across systems. Identify and communicate risks to study timelines or deliverables. Compile study and quality metrics for team review.
Team Communication: Act as a point of contact for clinical sites, vendors, and internal team members. Collaborate cross functionally with Clinical Operations, Data Management, Regulatory, and Safety teams.
Meetings: Coordinate and take minutes for project team meetings and investigator meetings. Track action items and follow up to ensure completion
Collaborate with relevant team members in coordination and tracking of vendor and investigator site budgets, contracts, invoices, and/or payments as needed.
Additional tasks as assigned
We offer flexible working models, competitive benefits, and an environment where you will have the opportunity for personal and professional growth.
ALX Oncology is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.
ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid checkpoint pathway. Our lead candidate, Evorpacept (ALX148), is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. Our second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and potential to be both first and best in class.
For more information about us, please visit www.alxoncology.com [http://www.alxoncology.com/].
Requires 1-3 years of clinical research experience, preferably in oncology or a startup biotech environment. A four-year degree is preferred along with proficiency in eTMF/EDC systems and knowledge of ICH-GCP regulations.
Market context
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