Sr. Clinical Trial Associate

POSITION SUMMARY:

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.

Study Documentation:

• 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

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

CORE COMPETENCIES:

• 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

QUALIFICATIONS AND SKILLS:

• Education: Four-year degree, focus in a related field preferred but not required
• Experience: 1–3 years in clinical research (CRO or sponsor environment). Experience supporting multiple clinical trials, preferably in oncology or complex therapeutic areas. Small/startup biotech environment a big plus.
• Knowledge: Working knowledge of ICH-GCP regulations. Understanding of clinical trial lifecycle, including startup, maintenance, and closeout activities
• Technical Skills: Proficiency in MS Office Suite (Excel, Word, PowerPoint) and eTMF/EDC systems (e.g., Veeva Vault). Familiarity with CTMS and document reconciliation processes preferred
• Attributes: Strong organizational skills, attention to detail, and ability to manage multiple tasks. Ability to work independently, exercise judgment, and escalate issues appropriately

WORK ENVIRONMENT AND ENVIRONMENTAL CONDITIONS:

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.

ABOUT ALX ONCOLOGY

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.