Sr. Clinical Trial Associate

ALX Oncology Inc.•South San Francisco, CA

About The Position

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.

Requirements

Four-year degree, focus in a related field preferred but not required
1–3 years in clinical research (CRO or sponsor environment).
Experience supporting multiple clinical trials, preferably in oncology or complex therapeutic areas.
Working knowledge of ICH-GCP regulations.
Understanding of clinical trial lifecycle, including startup, maintenance, and closeout activities
Proficiency in MS Office Suite (Excel, Word, PowerPoint) and eTMF/EDC systems (e.g., Veeva Vault).
Strong organizational skills, attention to detail, and ability to manage multiple tasks.
Ability to work independently, exercise judgment, and escalate issues appropriately
Understanding of the drug development process.
Ability to work within a team, yet work independently and display good judgement as to when to escalate issues and check in
Strong verbal and written communication.
Problem-solving and adaptability to shifting priorities
Ability to operate effectively in a fast paced, evolving startup environment
Strong prioritization and time management skills under competing demands
Collaborative mindset with ability to influence without direct authority

Nice To Haves

Small/startup biotech environment a big plus
Familiarity with CTMS and document reconciliation processes preferred

Responsibilities

Maintain electronic Trial Master Files (eTMF) and ensure documents comply with regulatory requirements
Perform ongoing TMF quality review and support inspection readiness, including identification and resolution of document gaps
Partner with CROs and internal teams to ensure timely filing and reconciliation of essential documents
Support TMF audits and health checks
Support Clinical Trial Manager (CTM), Study lead and Study Management Team (SMT) in study start up and executional activities
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
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.
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.
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.
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