Top 15 Clinical study manager Jobs in Austin, Tx

Clinical Research Associate
XBiotech USA, Inc —Austin, TX
- Full-time
- Nursing
- Mid-level
- 3 years
- Health savings account
- Health insurance
Quick Apply
4d
Clinical Research Project Manager - Project Hire
Senseye —Austin, TX
- $123,000 - $149,000 a year
- Full-time
- 5 years
- English
- Office
- Commuter assistance
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Late Phase Clinical Research Manager
Thermo Fisher Scientific —Austin, TX
- Full-time
- Mid-level
- Clinic
- Bachelor's degree
12d
Clinical Operations Manager
Pinnacle Clinical Research —Austin, TX
- Full-time
- Vital signs
- Mid-level
- 3 years
- Paid holidays
- Disability insurance
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10d
Clinical Research Coordinator
Planned Parenthood of Greater Texas —Austin, TX
- Weekends as needed
- Spanish
- Microsoft Excel
- Microsoft Outlook
Clinical Research Coordinator
Pinnacle Clinical Research —Austin, TX
- Full-time
- Spanish
- Vital signs
- BLS Certification
- Paid holidays
- Disability insurance
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Clinical Data Scientist
DiaSorin —Austin, TX
- Full-time
- Background check
- Writing skills
- Pass drug screening
Clinical Research Associate I
University of Texas at Austin —Austin, TX
- From $40,000 a year
- Full-time
- Nursing
- Psychiatry
- Office
- Retirement plan
Project Manager (Clinical Trials - Central Laboratory)
Sonic Clinical Trials USA, Inc —Austin, TX
- Full-time
- Customer service
- Bachelor of Science
- Mid-level
Imaging Support Specialist, Center for Biomedical Research Support
University of Texas at Austin —Austin, TX
- From $60,000 a year
- Urgently hiring
- Mid-level
- Master's degree
- Databases
- Paid holidays
- Health insurance
Round Rock -Clinical Research Coordinator I
Austin Retina Associates —Round Rock, TX
- Overtime
- Private practice
- Spanish
- Mid-level
Quick Apply
Nurse Practitioner-Sub-Investigator
Tekton Research Inc —Austin, TX
- Part-time
- Nursing
- Mid-level
- Office
Quick Apply
9d
Laboratory Technician / Clinical Research Coordinator
Eurofins USA Consumer Product Testing —Austin, TX
- $18 an hour
- Overtime
- HIPAA
- Bachelor's degree
- Organizational skills
- Paid holidays
- Disability insurance
Quick Apply
Austin-Clinical Research Coordinator I
Austin Retina Associates —Austin, TX
- Overtime
- Spanish
- 1 year
- Medical terminology
Quick Apply

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Clinical Research Associate

XBiotech USA, Inc -
Austin, TX

Quick Apply

Job Details

Full-time
4 days ago

Benefits

Health savings account
Health insurance
Dental insurance
401(k)
Paid time off
Parental leave
Vision insurance
Life insurance

Qualifications

Nursing
Teamwork
Clinical research
ICH guidelines
Bachelor's degree
Pharmacy
Research regulatory compliance
Cross-functional collaboration
Documentation review
Cross-functional communication

Full Job Description

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:

Bachelor's (preferred)

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

Education:

Bachelor's (Required)

Experience:

Clinical research: 5 years (Required)
clinical monitoring: 3 years (Required)

Ability to Commute:

Austin, TX 78744 (Preferred)

Willingness to travel:

75% (Required)

Work Location: In person

Quick Apply

Refine Your Search

clinical study manager jobs in austin, tx

Clinical Research Associate

Clinical Research Project Manager - Project Hire

Late Phase Clinical Research Manager

Clinical Operations Manager

Clinical Research Coordinator

Clinical Research Coordinator

Clinical Data Scientist

Clinical Research Associate I

Project Manager (Clinical Trials - Central Laboratory)

Imaging Support Specialist, Center for Biomedical Research Support

Round Rock -Clinical Research Coordinator I

Nurse Practitioner-Sub-Investigator

Laboratory Technician / Clinical Research Coordinator

Austin-Clinical Research Coordinator I

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