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.
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.
- 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.
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.