Job description:
XBiotech USA, Inc. is currently seeking a Clinical Trial Associate (CTA) to join our team in Austin, TX.
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development, and commercialization of therapeutic antibodies based on its True Human™ proprietary technology.
Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are 100 percent human, derived from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human™ antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy, and tolerability.
Clinical Trial Associate (CTA)
Position Summary
We are seeking a highly organized and proactive Clinical Trial Associate (CTA) to support the execution of clinical studies at a growing biotechnology company. The CTA will work closely with Clinical Research Associates (CRAs), investigators, study sites, and other cross-functional teams (Data Management, Safety, Quality, Regulatory, Supply Chain, etc.) to ensure clinical trial activities are completed accurately, efficiently, and in accordance with study requirements.
This is a hands-on role within a small biotech environment, offering the opportunity to contribute across multiple areas of clinical study operations. The successful candidate will be comfortable managing multiple priorities, coordinating with internal and external stakeholders, tracking study activities, and identifying issues that require follow-up.
Key Responsibilities
Clinical Trial Operations
- Support day-to-day operational activities for assigned clinical studies.
- Coordinate study activities with clinical sites, CROs, vendors, and internal team members.
- Maintain study trackers, action-item logs, enrollment reports, and study status reports.
- Track study milestones, deliverables, and timelines and follow up on outstanding items.
- Support preparation and coordination of study team meetings and maintain meeting minutes and action items.
- Assist with study start-up, site activation, ongoing site management, and study close-out activities. Travel is required for site visits.
- Support the Clinical Operations team in identifying and resolving operational issues.
Site and Vendor Coordination
- Serve as an operational point of contact for assigned study sites and external partners.
- Coordinate site communications and follow up on required documents, training, and study activities.
- Track site activation and enrollment progress.
- Support vendor oversight by monitoring deliverables, timelines, and open action items.
- Escalate significant or recurring issues to the appropriate Clinical Operations team member.
Clinical Documentation
- Support maintenance of the Trial Master File (TMF) and ensure required documents are collected, reviewed, and filed appropriately.
- Assist with essential document tracking and reconciliation.
- Support document collection from clinical sites and CROs.
- Maintain accurate study records in accordance with company procedures.
- Assist with preparation for audits and regulatory inspections.
Study Systems and Data Tracking
- Maintain study information in clinical trial management systems (CTMS) and other study databases.
- Track enrollment, site performance, monitoring activities, outstanding issues, and study milestones.
- Prepare routine reports and dashboards for the Clinical Operations team.
- Identify discrepancies or missing information and coordinate appropriate follow-up.
Cross-Functional Collaboration
- Work with Clinical Operations, Regulatory Affairs, Quality Assurance, Data Management, Medical Affairs, and other internal teams as needed.
- Coordinate information across multiple stakeholders to ensure timely completion of study activities.
- Participate in cross-functional study meetings and contribute to operational planning.
- Support process improvement initiatives within Clinical Operations.
Qualifications
- Bachelor's degree in Life Sciences, Healthcare, Business, Engineering, Project Management, or a related field.
- 2–5 years of experience in clinical research, clinical operations, project coordination, healthcare operations, life sciences, or a related field.
- Experience working in a regulated environment is preferred.
- Strong organizational and project coordination skills.
- Excellent attention to detail and ability to manage multiple priorities.
- Strong written and verbal communication skills.
- Ability to work independently while collaborating effectively with a small, cross-functional team.
- Proficiency with Microsoft Office, particularly Excel and PowerPoint.
Preferred Qualifications
- Previous experience in a pharmaceutical, biotechnology, CRO, clinical research organization, or healthcare environment.
- Familiarity with ICH-GCP and clinical trial processes.
- Experience with CTMS, eTMF, EDC, or other clinical trial systems.
- Experience coordinating vendors, contractors, or external partners.
- Experience with project management or process improvement.
- Knowledge of clinical trial documentation and essential documents.
- Experience supporting clinical study start-up or site activation.
The ideal candidate is a highly organized problem solver who can keep multiple workstreams moving simultaneously. Because we are a small biotech company, the individual should be comfortable taking ownership of tasks, communicating directly with internal and external stakeholders, and working in an environment where responsibilities may evolve as the company and clinical programs grow.
Candidates with backgrounds in business, engineering, project management, operations, or other regulated industries are encouraged to apply. Clinical research experience is preferred, but strong candidates with transferable project and operational experience may be considered.
The successful candidate will:
- Develop a strong understanding of the company's clinical studies and operational processes.
- Effectively coordinate study activities and follow up on outstanding deliverables.
- Maintain accurate and timely clinical documentation.
- Build productive relationships with CROs, sites, and internal stakeholders.
- Provide reliable study tracking and status information to Clinical Operations.
- Identify operational issues early and ensure appropriate follow-up.
- Contribute to improvements in clinical trial processes and systems.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Education:
Experience:
- Clinical research: 2+ years
- Project coordination: 2+ years
Work Location: In person
Travel: Required, including domestic and international travel.
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Education:
Experience:
- Clinical research: 2 years (Preferred)
- Project management: 2 years (Preferred)
Ability to Commute:
- Austin, TX 78744 (Required)
Willingness to travel:
Work Location: In person
