Job description:
XBiotech USA, Inc. is currently seeking an experienced Clinical Research Associate (CRA) 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 Research Associate (CRA)
Position Summary
The Clinical Research Associate (CRA) is responsible for providing clinical trial oversight and monitoring activities on behalf of the Sponsor. The CRA will manage relationships with assigned clinical research sites and ensure that clinical trials are conducted in accordance with the protocol, ICH-GCP, applicable regulatory requirements, and Sponsor standard operating procedures (SOPs).
The CRA will work closely with Site Managers, Medical, Data Management, Regulatory Affairs, Pharmacovigilance, and other cross-functional teams to ensure high-quality and timely execution of clinical studies.
Key Responsibilities
Clinical Trial Monitoring
- Conduct site qualification, initiation, routine monitoring, and close-out visits in accordance with the monitoring plan.
- Ensure study sites conduct clinical trials according to the protocol, ICH-GCP, applicable regulations, and Sponsor requirements.
- Review source documentation, essential documents, informed consent documentation, and clinical data for quality and compliance.
- Identify, document, and follow up on protocol deviations, data discrepancies, and site compliance issues.
- Perform ongoing review of site performance, enrollment, data quality, query resolution, and overall study conduct.
- Prepare accurate and timely monitoring visit reports and follow-up communications.
- Ensure timely resolution and documentation of monitoring findings.
Site Management: Collaborate with Site Managers and
- Develop and maintain effective working relationships with Principal Investigators and site study teams.
- Provide training and ongoing support to site personnel regarding study procedures and protocol requirements.
- Monitor site recruitment and retention activities and identify potential enrollment risks.
- Support sites in resolving operational issues and escalating significant concerns appropriately.
- Ensure appropriate accountability and reconciliation of investigational product and study supplies, where applicable.
Sponsor Oversight
- Maintain direct oversight of assigned clinical sites and ensure compliance with the Sponsor's quality management system.
- Collaborate with Site Managers and study leadership to identify and mitigate site-level risks.
- Contribute to risk-based quality management and centralized monitoring activities.
- Support inspection readiness and ensure clinical trial documentation is maintained appropriately in the TMF.
Cross-Functional Collaboration
- Participate in study team meetings and provide updates regarding site status, enrollment, quality, and operational risks.
- Collaborate with Data Management on data review, query resolution, and data quality issues.
- Work with Medical and Safety teams to escalate potential safety or protocol-related concerns.
- Partner with Regulatory Affairs and other functions on study start-up, amendments, and regulatory activities as needed.
- Support study planning, enrollment forecasting, and operational risk assessment.
Qualifications
- Bachelor's degree in life sciences, nursing, pharmacy, or a related scientific or healthcare discipline.
- Typically 5+ years of clinical research experience, including 3+ years of clinical monitoring experience.
- Direct sponsor-side or CRO experience in clinical trial monitoring preferred.
- Strong knowledge of ICH-GCP and applicable clinical research regulations.
- Experience conducting or supporting site qualification, initiation, monitoring, and close-out activities.
- Experience with EDC, CTMS, eTMF, and other clinical trial systems.
- Strong understanding of clinical trial documentation and essential documents.
- Excellent communication, organizational, and problem-solving skills.
- Ability to work independently while effectively collaborating with cross-functional teams.
- Ability and willingness to travel to clinical research sites as required.
Preferred Qualifications
- Experience managing clinical trials from study start-up through database lock and study close-out.
- Experience with risk-based monitoring and centralized monitoring approaches.
- Experience in the Sponsor environment, particularly in a small or mid-sized pharmaceutical or biotechnology company.
- Rheumatology/Immunology experience preferred.
- Clinical research certification such as CCRA, CCRP, or equivalent.
Key Success Measures
- Timely and high-quality monitoring of assigned sites.
- Site compliance with protocol, GCP, and regulatory requirements.
- Effective identification and resolution of site issues.
- Strong site relationships and appropriate investigator engagement.
- High-quality clinical trial data and documentation.
- Timely escalation and mitigation of study risks.
- Consistent execution of Sponsor quality and clinical operations standards.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Education:
Experience:
- Clinical trial monitoring: 3+ years
Work Location: In person
Travel: Required, including domestic and international travel.
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
- Parental leave
- Vision insurance
Medical Specialty:
Education:
Experience:
- Clinical research: 5 years (Preferred)
- clinical monitoring: 3 years (Preferred)
Work Location: In person
